Calculation of Hazard Category 2/3 Threshold Quantities Using Contemporary Dosimetric Data

DOE Office of Scientific and Technical Information (OSTI.GOV)

Walker, William C.

The purpose of this report is to describe the methodology and selection of input data utilized to calculate updated Hazard Category 2 and Hazard Category 3 Threshold Quantities (TQs) using contemporary dosimetric information. The calculation of the updated TQs will be considered for use in the revision to the Department of Energy (DOE) Technical Standard (STD-) 1027-92 Change Notice (CN)-1, “Hazard Categorization and Accident Analysis Techniques for Compliance with DOE Order 5480.23, Nuclear Safety Analysis Reports.” The updated TQs documented in this report complement an effort previously undertaken by the National Nuclear Security Administration (NNSA), which in 2014 issued revisedmore » Supplemental Guidance documenting the calculation of updated TQs for approximately 100 radionuclides listed in DOE-STD-1027-92, CN-1. The calculations documented in this report complement the NNSA effort by expanding the set of radionuclides to more than 1,250 radionuclides with a published TQ. The development of this report was sponsored by the Department of Energy’s Office of Nuclear Safety (AU-30) within the Associate Under Secretary for Environment, Health, Safety, and Security organization.« less

76 FR 10246 - Updating Fire Safety Standards

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-24

... DEPARTMENT OF VETERANS AFFAIRS 38 CFR Parts 17 and 59 RIN 2900-AN57 Updating Fire Safety Standards... regulations and update the standards for VA approval of such facilities, including standards for fire safety... to ``RIN 2900-AN57--Updating Fire Safety [[Page 10247

10 CFR 72.240 - Conditions for spent fuel storage cask renewal.

Code of Federal Regulations, 2013 CFR

2013-01-01

... to exceed 40 years. In the event that the certificate holder does not apply for a cask design renewal...) The application must be accompanied by a safety analysis report (SAR). The SAR must include the following: (1) Design bases information as documented in the most recently updated final safety analysis...

10 CFR 72.240 - Conditions for spent fuel storage cask renewal.

Code of Federal Regulations, 2012 CFR

2012-01-01

... to exceed 40 years. In the event that the certificate holder does not apply for a cask design renewal...) The application must be accompanied by a safety analysis report (SAR). The SAR must include the following: (1) Design bases information as documented in the most recently updated final safety analysis...

10 CFR 72.240 - Conditions for spent fuel storage cask renewal.

Code of Federal Regulations, 2014 CFR

2014-01-01

... to exceed 40 years. In the event that the certificate holder does not apply for a cask design renewal...) The application must be accompanied by a safety analysis report (SAR). The SAR must include the following: (1) Design bases information as documented in the most recently updated final safety analysis...

Update from C3RS lessons learned team : safety culture and trend analysis.

DOT National Transportation Integrated Search

2014-07-01

The Federal Railroad Administration (FRA) believes that, in addition to process and technology innovations, human-factors-based solutions can significantly contribute to improving safety in the railroad industry. To test this assumption, FRA implemen...

Analysis of new entrant motor carrier safety performance and compliance using SafeStat

DOT National Transportation Integrated Search

2000-03-01

This report documents the findings of a special study undertaken to update, confirm and expand upon previous studies on the comparative (to experienced carriers) safety performance and compliance of large commercial motor vehicle operators (motor car...

Status update on GPS integrity failure modes and effects analysis

DOT National Transportation Integrated Search

2004-01-01

GPS integrity anomalies have long been of great concern to the civil and military GPS communities for safety-of- life operations. The FAA, USCG, and their international counterparts have focused on how to accomplish integrity monitoring for safety-of...

75 FR 17641 - Updating Fire Safety Standards

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-07

... DEPARTMENT OF VETERANS AFFAIRS 38 CFR Parts 17 and 59 RIN 2900-AN57 Updating Fire Safety Standards... for VA approval of such facilities, including standards for fire safety and heating and cooling... submitted in response to ``RIN 2900-AN57--Updating Fire Safety Standards.'' Copies of comments received will...

Limited-scope probabilistic safety analysis for the Los Alamos Meson Physics Facility (LAMPF)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sharirli, M.; Rand, J.L.; Sasser, M.K.

1992-01-01

The reliability of instrumentation and safety systems is a major issue in the operation of accelerator facilities. A probabilistic safety analysis was performed or the key safety and instrumentation systems at the Los Alamos Meson Physics Facility (LAMPF). in Phase I of this unique study, the Personnel Safety System (PSS) and the Current Limiters (XLs) were analyzed through the use of the fault tree analyses, failure modes and effects analysis, and criticality analysis. Phase II of the program was done to update and reevaluate the safety systems after the Phase I recommendations were implemented. This paper provides a brief reviewmore » of the studies involved in Phases I and II of the program.« less

Limited-scope probabilistic safety analysis for the Los Alamos Meson Physics Facility (LAMPF)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sharirli, M.; Rand, J.L.; Sasser, M.K.

1992-12-01

The reliability of instrumentation and safety systems is a major issue in the operation of accelerator facilities. A probabilistic safety analysis was performed or the key safety and instrumentation systems at the Los Alamos Meson Physics Facility (LAMPF). in Phase I of this unique study, the Personnel Safety System (PSS) and the Current Limiters (XLs) were analyzed through the use of the fault tree analyses, failure modes and effects analysis, and criticality analysis. Phase II of the program was done to update and reevaluate the safety systems after the Phase I recommendations were implemented. This paper provides a brief reviewmore » of the studies involved in Phases I and II of the program.« less

Using resources for scientific-driven pharmacovigilance: from many product safety documents to one product safety master file.

PubMed

Furlan, Giovanni

2012-08-01

Current regulations require a description of the overall safety profile or the specific risks of a drug in multiple documents such as the Periodic and Development Safety Update Reports, Risk Management Plans (RMPs) and Signal Detection Reports. In a resource-constrained world, the need for preparing multiple documents reporting the same information results in shifting the focus from a thorough scientific and medical evaluation of the available data to maintaining compliance with regulatory timelines. Since the aim of drug safety is to understand and characterize product issues to take adequate risk minimization measures rather than to comply with bureaucratic requirements, there is the need to avoid redundancy. In order to identify core drug safety activities that need to be undertaken to protect patient safety and reduce the number of documents reporting the results of these activities, the author has reviewed the main topics included in the drug safety guidelines and templates. The topics and sources that need to be taken into account in the main regulatory documents have been found to greatly overlap and, in the future, as a result of the new Periodic Safety Update Report structure and requirements, in the author's opinion this overlap is likely to further increase. Many of the identified inter-document differences seemed to be substantially formal. The Development Safety Update Report, for example, requires separate presentation of the safety issues emerging from different sources followed by an overall evaluation of each safety issue. The RMP, instead, requires a detailed description of the safety issues without separate presentation of the evidence derived from each source. To some extent, however, the individual documents require an in-depth analysis of different aspects; the RMP, for example, requires an epidemiological description of the indication for which the drug is used and its risks. At the time of writing this article, this is not specifically required by other documents. The author has identified signal detection (intended not only as adverse event disproportionate reporting, but including non-clinical, laboratory, clinical analysis data and literature screening) and characterization as the basis for the preparation of all drug safety documents, which can be viewed as different ways of presenting the results of this activity. Therefore, the author proposes to merge all the aggregate reports required by current regulations into a single document - the Drug Safety Master File. This report should contain all the available information, from any source, regarding the potential and identified risks of a drug. It should be a living document updated and submitted to regulatory authorities on an ongoing basis.

77 FR 41258 - FOIA Fee Schedule Update

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-13

... DEFENSE NUCLEAR FACILITIES SAFETY BOARD 10 CFR Part 1703 FOIA Fee Schedule Update AGENCY: Defense Nuclear Facilities Safety Board. ACTION: Establishment of FOIA Fee Schedule. SUMMARY: The Defense Nuclear Facilities Safety Board is publishing its Freedom of Information Act (FOIA) Fee Schedule Update pursuant to...

76 FR 43819 - FOIA Fee Schedule Update

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-22

... DEFENSE NUCLEAR FACILITIES SAFETY BOARD 10 CFR Part 1703 FOIA Fee Schedule Update AGENCY: Defense Nuclear Facilities Safety Board. ACTION: Establishment of FOIA Fee Schedule. SUMMARY: The Defense Nuclear Facilities Safety Board is publishing its Freedom of Information Act (FOIA) Fee Schedule Update pursuant to...

75 FR 2564 - Virginia Electric and Power Company D/B/A Dominion Virginia Power and Old Dominion Electric...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-15

..., submit an annual update to the application's final safety analysis report (FSAR), which is a part of the... public health or safety, and are consistent with the common defense and security; and (2) special... is authorized by law. No Undue Risk to Public Health and Safety The underlying purpose of 10 CFR 50...

75 FR 51525 - Railroad Safety Advisory Committee (RSAC); Working Group Activity Update

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-20

.... 63] Railroad Safety Advisory Committee (RSAC); Working Group Activity Update AGENCY: Federal Railroad... Committee (RSAC) Working Group Activities. SUMMARY: The FRA is updating its announcement of RSAC's Working.... SUPPLEMENTARY INFORMATION: This notice serves to update FRA's last announcement of working group activities and...

Overview of Energy Systems` safety analysis report programs. Safety Analysis Report Update Program

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1992-03-01

The primary purpose of an Safety Analysis Report (SAR) is to provide a basis for judging the adequacy of a facility`s safety. The SAR documents the safety analyses that systematically identify the hazards posed by the facility, analyze the consequences and risk of potential accidents, and describe hazard control measures that protect the health and safety of the public and employees. In addition, some SARs document, as Technical Safety Requirements (TSRs, which include Technical Specifications and Operational Safety Requirements), technical and administrative requirements that ensure the facility is operated within prescribed safety limits. SARs also provide conveniently summarized information thatmore » may be used to support procedure development, training, inspections, and other activities necessary to facility operation. This ``Overview of Energy Systems Safety Analysis Report Programs`` Provides an introduction to the programs and processes used in the development and maintenance of the SARs. It also summarizes some of the uses of the SARs within Energy Systems and DOE.« less

75 FR 4904 - Railroad Safety Advisory Committee (RSAC); Working Group Activity Update

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-29

...-7257] Railroad Safety Advisory Committee (RSAC); Working Group Activity Update AGENCY: Federal Railroad... Committee (RSAC) Working Group Activities. SUMMARY: The FRA is updating its announcement of RSAC's Working... notice serves to update FRA's last announcement of working group activities and status reports of August...

77 FR 24257 - Railroad Safety Advisory Committee (RSAC); Working Group Activity Update

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-23

.... 69] Railroad Safety Advisory Committee (RSAC); Working Group Activity Update AGENCY: Federal Railroad... Committee (RSAC) Working Group Activities. SUMMARY: The FRA is updating its announcement of the RSAC Working.... SUPPLEMENTARY INFORMATION: This notice serves to update FRA's last announcement of working group activities and...

75 FR 76070 - Railroad Safety Advisory Committee (RSAC); Working Group Activity Update

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-07

.... 65] Railroad Safety Advisory Committee (RSAC); Working Group Activity Update AGENCY: Federal Railroad... Committee (RSAC) Working Group Activities. SUMMARY: The FRA is updating its announcement of RSAC's Working.... [[Page 76071

77 FR 21782 - International Conference on Harmonisation; Draft Guidance for Industry on E2C(R2) Periodic...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-11

... electronic submission of individual case safety reports to regulatory authorities, automated data mining... Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (addendum...

75 FR 17644 - Update to NFPA 101, Life Safety Code, for State Home Facilities

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-07

... DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 51 RIN 2900-AN59 Update to NFPA 101, Life Safety Code... certain provisions of the 2009 edition of the National Fire Protection Association's NFPA 101, Life Safety... standards regarding life safety and fire safety. DATES: Written comments must be received by VA on or before...

76 FR 11339 - Update to NFPA 101, Life Safety Code, for State Home Facilities

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-02

... DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 51 RIN 2900-AN59 Update to NFPA 101, Life Safety Code..., Life Safety Code. The change is designed to assure that State Home facilities meet current industry- wide standards regarding life safety and fire safety. DATES: Effective Date: This final rule is...

Updating a Strategic Highway Safety Plan : Learning from the Idaho Transportation Department (ITD) - Proceedings from the Federal Highway Administration's (FHWA) Highway Safety Peer-to-Peer Exchange Program

DOT National Transportation Integrated Search

2009-10-01

On November 4, 2009, ITDs Office of Highway Operations and Safety partnered with the FHWA Office of Safety to host a one-day peer exchange. This event focused on the update of Idahos Strategic Highway Safety Plan (SHSP), entitled Toward Zero...

Updating Rhode Island’s Strategic Highway Safety Plan (SHSP) : an RSPCB Peer Exchange

DOT National Transportation Integrated Search

2012-03-01

In January 2012, Rhode Island kicked off its Strategic Highway Safety Plan (SHSP) update with a leadership committee meeting where key safety stakeholders presented an overview of Rhode Islands accomplishments since initial SHSP approval in 2007. ...

Postmarket Safety Outcomes for New Molecular Entity (NME) Drugs Approved by the Food and Drug Administration Between 2002 and 2014.

PubMed

Pinnow, Ellen; Amr, Sania; Bentzen, Søren M; Brajovic, Sonja; Hungerford, Laura; St George, Diane Marie; Dal Pan, Gerald

2017-12-20

We ascertained a comprehensive list of postmarket safety outcomes, defined as a safety-related market withdrawal or an update to a safety-related section of product label for 278 new molecular entity drugs (NMEs) with a follow-up period of up to 13 years. At least one safety-related update was added to 195 (70.1%) labels of the drugs studied. Updates occurred as early as 160 days after approval and throughout the follow-up period. The period between the second and eighth postapproval year was the most active, with a slight attenuation thereafter. The times to the first safety outcome were significantly shorter for NMEs approved with a fast-track designation (P = 0.02) or under an accelerated approval using a surrogate endpoint (P = 0.03). Our findings underscore the importance of a robust safety surveillance system throughout a drug's lifecycle and for practitioners and patients to remain updated on drug safety profiles. © 2017, The American Society for Clinical Pharmacology and Therapeutics.

Prescription Weight-Loss Drugs: Can They Help You?

MedlinePlus

... term pharmacotherapy for obesity and overweight: Updated meta-analysis. BMJ. 2007;335:1194. Meridia (sibutramine): Market withdrawal due to risk of serious cardiovascular events. U.S. Food and Drug Administration. http://www.fda.gov/Safety/ ...

78 FR 23898 - Notice of Request for a New Information Collection (Accredited Laboratory Contact Update Form)

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-23

... Request for a New Information Collection (Accredited Laboratory Contact Update Form) AGENCY: Food Safety... compilation of updated contact information for Accredited Laboratories. DATES: Comments on this notice must be... FURTHER INFORMATION CONTACT: Contact John O'Connell, Paperwork Reduction Act Coordinator, Food Safety and...

75 FR 48593 - Pipeline Safety: Periodic Updates of Regulatory References to Technical Standards and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-11

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Parts... AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), Department of Transportation (DOT... action allows pipeline operators to use current technologies, improved materials, and updated industry...

A Bayesian procedure for evaluating the frequency of calibration factor updates in highway safety manual (HSM) applications.

PubMed

Saha, Dibakar; Alluri, Priyanka; Gan, Albert

2017-01-01

The Highway Safety Manual (HSM) presents statistical models to quantitatively estimate an agency's safety performance. The models were developed using data from only a few U.S. states. To account for the effects of the local attributes and temporal factors on crash occurrence, agencies are required to calibrate the HSM-default models for crash predictions. The manual suggests updating calibration factors every two to three years, or preferably on an annual basis. Given that the calibration process involves substantial time, effort, and resources, a comprehensive analysis of the required calibration factor update frequency is valuable to the agencies. Accordingly, the objective of this study is to evaluate the HSM's recommendation and determine the required frequency of calibration factor updates. A robust Bayesian estimation procedure is used to assess the variation between calibration factors computed annually, biennially, and triennially using data collected from over 2400 miles of segments and over 700 intersections on urban and suburban facilities in Florida. Bayesian model yields a posterior distribution of the model parameters that give credible information to infer whether the difference between calibration factors computed at specified intervals is credibly different from the null value which represents unaltered calibration factors between the comparison years or in other words, zero difference. The concept of the null value is extended to include the range of values that are practically equivalent to zero. Bayesian inference shows that calibration factors based on total crash frequency are required to be updated every two years in cases where the variations between calibration factors are not greater than 0.01. When the variations are between 0.01 and 0.05, calibration factors based on total crash frequency could be updated every three years. Copyright © 2016 Elsevier Ltd. All rights reserved.

75 FR 27228 - Proposed FOIA Fee Schedule Update

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-14

... DEFENSE NUCLEAR FACILITIES SAFETY BOARD 10 CFR Part 1703 Proposed FOIA Fee Schedule Update AGENCY: Defense Nuclear Facilities Safety Board. ACTION: Notice of proposed rulemaking. SUMMARY: Pursuant to 10 CFR 1703.107(b)(6) of the Board's regulations, the Defense Nuclear Facilities Safety Board is...

76 FR 28194 - Proposed FOIA Fee Schedule Update

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-16

... DEFENSE NUCLEAR FACILITIES SAFETY BOARD 10 CFR Part 1703 Proposed FOIA Fee Schedule Update AGENCY: Defense Nuclear Facilities Safety Board. ACTION: Notice of proposed rulemaking. SUMMARY: Pursuant to 10 CFR 1703.107(b)(6) of the Board's regulations, the Defense Nuclear Facilities Safety Board is...

DARHT: INTEGRATION OF AUTHORIZATION BASIS REQUIREMENTS AND WORKER SAFETY

DOE Office of Scientific and Technical Information (OSTI.GOV)

D. A. MC CLURE; C. A. NELSON; R. L. BOUDRIE

2001-04-01

This document describes the results of consensus agreements reached by the DARHT Safety Planning Team during the development of the update of the DARHT Safety Analysis Document (SAD). The SAD is one of the Authorization Basis (AB) Documents required by the Department prior to granting approval to operate the DARHT Facility. The DARHT Safety Planning Team is lead by Mr. Joel A. Baca of the Department of Energy Albuquerque Operations Office (DOE/AL). Team membership is drawn from the Department of Energy Albuquerque Operations Office, the Department of Energy Los Alamos Area Office (DOE/LAAO), and several divisions of the Los Alamosmore » National Laboratory. Revision 1 of the DARHT SAD had been written as part of the process for gaining approval to operate the Phase 1 (First Axis) Accelerator. Early in the planning stage for the required update of the SAD for the approval to operate both Phase 1 and Phase 2 (First Axis and Second Axis) DARHT Accelerator, it was discovered that a conflict existed between the Laboratory approach to describing the management of facility and worker safety.« less

Guidance on health effects of toxic chemicals. Safety Analysis Report Update Program

DOE Office of Scientific and Technical Information (OSTI.GOV)

Foust, C.B.; Griffin, G.D.; Munro, N.B.

1994-02-01

Martin Marietta Energy Systems, Inc. (MMES), and Martin Marietta Utility Services, Inc. (MMUS), are engaged in phased programs to update the safety documentation for the existing US Department of Energy (DOE)-owned facilities. The safety analysis of potential toxic hazards requires a methodology for evaluating human health effects of predicted toxic exposures. This report provides a consistent set of health effects and documents toxicity estimates corresponding to these health effects for some of the more important chemicals found within MMES and MMUS. The estimates are based on published toxicity information and apply to acute exposures for an ``average`` individual. The healthmore » effects (toxicological endpoints) used in this report are (1) the detection threshold; (2) the no-observed adverse effect level; (3) the onset of irritation/reversible effects; (4) the onset of irreversible effects; and (5) a lethal exposure, defined to be the 50% lethal level. An irreversible effect is defined as a significant effect on a person`s quality of life, e.g., serious injury. Predicted consequences are evaluated on the basis of concentration and exposure time.« less

76 FR 70885 - Updating Fire Safety Standards

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-16

... DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 59 RIN 2900-AN57 Updating Fire Safety Standards AGENCY... Fire Protection Association (NFPA) 101. This rule helps ensure the safety of veterans in the affected... publications are: NFPA 10, Standard for Portable Fire Extinguishers; NFPA 99, Standard for Health Care...

Methanol test

MedlinePlus

... Safety and Health. Emergency Response Safety and Health Database. Methanol: systemic agent. Updated May 28, 2015. www. ... ADAM Health Solutions. About MedlinePlus Site Map FAQs Customer Support Get email updates Subscribe to RSS Follow ...

Pivotal ERIVANCE basal cell carcinoma (BCC) study: 12-month update of efficacy and safety of vismodegib in advanced BCC.

PubMed

Sekulic, Aleksandar; Migden, Michael R; Lewis, Karl; Hainsworth, John D; Solomon, James A; Yoo, Simon; Arron, Sarah T; Friedlander, Philip A; Marmur, Ellen; Rudin, Charles M; Chang, Anne Lynn S; Dirix, Luc; Hou, Jeannie; Yue, Huibin; Hauschild, Axel

2015-06-01

Primary analysis from the pivotal ERIVANCE BCC study resulted in approval of vismodegib, a Hedgehog pathway inhibitor indicated for treatment of adults with metastatic or locally advanced basal cell carcinoma (BCC) that has recurred after surgery or for patients who are not candidates for surgery or radiation. An efficacy and safety analysis was conducted 12 months after primary analysis. This was a multinational, multicenter, nonrandomized, 2-cohort study in patients with measurable and histologically confirmed locally advanced or metastatic BCC taking oral vismodegib (150 mg/d). Primary outcome measure was objective response rate (complete and partial responses) assessed by independent review facility. After 12 months of additional follow-up, median duration of exposure to vismodegib was 12.9 months. Objective response rate increased from 30.3% to 33.3% in patients with metastatic disease, and from 42.9% to 47.6% in patients with the locally advanced form. Median duration of response in patients with locally advanced BCC increased from 7.6 to 9.5 months. No new safety signals emerged with extended treatment duration. Limitations include low prevalence of advanced BCC and challenges of designing a study with heterogenous manifestations. The 12-month update of the study confirms the efficacy and safety of vismodegib in management of advanced BCC. Copyright © 2015 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Aggregate analysis of regulatory authority assessors' comments to improve the quality of periodic safety update reports.

PubMed

Jullian, Sandra; Jaskiewicz, Lukasz; Pfannkuche, Hans-Jürgen; Parker, Jeremy; Lalande-Luesink, Isabelle; Lewis, David J; Close, Philippe

2015-09-01

Marketing authorization holders (MAHs) are expected to provide high-quality periodic safety update reports (PSURs) on their pharmaceutical products to health authorities (HAs). We present a novel instrument aiming at improving quality of PSURs based on standardized analysis of PSUR assessment reports (ARs) received from the European Union HAs across products and therapeutic areas. All HA comments were classified into one of three categories: "Request for regulatory actions," "Request for medical and scientific information," or "Data deficiencies." The comments were graded according to their impact on patients' safety, the drug's benefit-risk profile, and the MAH's pharmacovigilance system. A total of 476 comments were identified through the analysis of 63 PSUR HA ARs received in 2013 and 2014; 47 (10%) were classified as "Requests for regulatory actions," 309 (65%) as "Requests for medical and scientific information," and 118 (25%) comments were related to "Data deficiencies." The most frequent comments were requests for labeling changes (35 HA comments in 19 ARs). The aggregate analysis revealed commonly raised issues and prompted changes of the MAH's procedures related to the preparation of PSURs. The authors believe that this novel instrument based on the evaluation of PSUR HA ARs serves as a valuable mechanism to enhance the quality of PSURs and decisions about optimization of the use of the products and, therefore, contributes to improve further the MAH's pharmacovigilance system and patient safety. Copyright © 2015 John Wiley & Sons, Ltd.

75 FR 36773 - Pipeline Safety: Updating Facility Response Plans in Light of the Deepwater Horizon Oil Spill

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-28

.... PHMSA-2010-0175] Pipeline Safety: Updating Facility Response Plans in Light of the Deepwater Horizon Oil... 194. In light of the Deepwater Horizon oil spill in the Gulf of Mexico, which has resulted in the... Systems. Subject: Updating Facility Response Plans in Light of the Deepwater Horizon Oil Spill. Advisory...

Integrate genome-based assessment of safety for probiotic strains: Bacillus coagulans GBI-30, 6086 as a case study.

PubMed

Salvetti, Elisa; Orrù, Luigi; Capozzi, Vittorio; Martina, Alessia; Lamontanara, Antonella; Keller, David; Cash, Howard; Felis, Giovanna E; Cattivelli, Luigi; Torriani, Sandra; Spano, Giuseppe

2016-05-01

Probiotics are microorganisms that confer beneficial effects on the host; nevertheless, before being allowed for human consumption, their safety must be verified with accurate protocols. In the genomic era, such procedures should take into account the genomic-based approaches. This study aims at assessing the safety traits of Bacillus coagulans GBI-30, 6086 integrating the most updated genomics-based procedures and conventional phenotypic assays. Special attention was paid to putative virulence factors (VF), antibiotic resistance (AR) genes and genes encoding enzymes responsible for harmful metabolites (i.e. biogenic amines, BAs). This probiotic strain was phenotypically resistant to streptomycin and kanamycin, although the genome analysis suggested that the AR-related genes were not easily transferrable to other bacteria, and no other genes with potential safety risks, such as those related to VF or BA production, were retrieved. Furthermore, no unstable elements that could potentially lead to genomic rearrangements were detected. Moreover, a workflow is proposed to allow the proper taxonomic identification of a microbial strain and the accurate evaluation of risk-related gene traits, combining whole genome sequencing analysis with updated bioinformatics tools and standard phenotypic assays. The workflow presented can be generalized as a guideline for the safety investigation of novel probiotic strains to help stakeholders (from scientists to manufacturers and consumers) to meet regulatory requirements and avoid misleading information.

AAP Updates Recommendations on Car Seats

MedlinePlus

... Size Email Print Share AAP Updates Recommendations on Car Seats Page Content Article Body Children should ride ... of approved car safety seats. Healthy Children Radio: Car Seat Safety Dennis Durbin, MD, FAAP, lead author ...

DOE interpretations Guide to OSH standards. Update to the Guide

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1994-03-31

Reflecting Secretary O`Leary`s focus on occupational safety and health, the Office of Occupational Safety is pleased to provide you with the latest update to the DOE Interpretations Guide to OSH Standards. This Guide was developed in cooperation with the Occupational Safety and Health Administration, which continued its support during this last revision by facilitating access to the interpretations found on the OSHA Computerized Information System (OCIS). This March 31, 1994 update contains 123 formal interpretation letters written OSHA. As a result of the unique requests received by the 1-800 Response Line, this update also contains 38 interpretations developed by DOE.more » This new occupational safety and health information adds still more important guidance to the four volume reference set that you presently have in your possession.« less

DOE interpretations Guide to OSH standards. Update to the Guide

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1994-03-31

Reflecting Secretary O`Leary`s focus on occupational safety and health, the Office of Occupational Safety is pleased to provide you with the latest update to the DOE Interpretations Guide to OSH Standards. This Guide was developed in cooperation with the Occupational Safety and Health Administration, which continued it`s support during this last revision by facilitating access to the interpretations found on the OSHA Computerized Information System (OCIS). This March 31, 1994 update contains 123 formal in letter written by OSHA. As a result of the unique requests received by the 1-800 Response Line, this update also contains 38 interpretations developed bymore » DOE. This new occupational safety and health information adds still more important guidance to the four volume reference set that you presently have in your possession.« less

Operating & Environmental Standards « Coast Guard Maritime Commons

Science.gov Websites

: Marine Safety Information Bulletin 03-18, Oily bilge water management This bulletin summarizes key legal updates to Marine Safety Center's ballast water management system website The Marine Safety Center recently updated two tools posted to its ballast water management system website to assist industry when

Capillary electrophoresis for the analysis of contaminants in emerging food safety issues and food traceability.

PubMed

Vallejo-Cordoba, Belinda; González-Córdova, Aarón F

2010-07-01

This review presents an overview of the applicability of CE in the analysis of chemical and biological contaminants involved in emerging food safety issues. Additionally, CE-based genetic analyzers' usefulness as a unique tool in food traceability verification systems was presented. First, analytical approaches for the determination of melamine and specific food allergens in different foods were discussed. Second, natural toxin analysis by CE was updated from the last review reported in 2008. Finally, the analysis of prion proteins associated with the "mad cow" crises and the application of CE-based genetic analyzers for meat traceability were summarized.

77 FR 48112 - Pipeline Safety: Administrative Procedures; Updates and Technical Corrections

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-13

...This Notice of Proposed Rulemaking updates the administrative civil penalty maximums for violation of the pipeline safety regulations to conform to current law, updates the informal hearing and adjudication process for pipeline enforcement matters to conform to current law, amends other administrative procedures used by PHMSA personnel, and makes other technical corrections and updates to certain administrative procedures. The proposed amendments do not impose any new operating, maintenance, or other substantive requirements on pipeline owners or operators.

DATMAN: A reliability data analysis program using Bayesian updating

DOE Office of Scientific and Technical Information (OSTI.GOV)

Becker, M.; Feltus, M.A.

1996-12-31

Preventive maintenance (PM) techniques focus on the prevention of failures, in particular, system components that are important to plant functions. Reliability-centered maintenance (RCM) improves on the PM techniques by introducing a set of guidelines by which to evaluate the system functions. It also minimizes intrusive maintenance, labor, and equipment downtime without sacrificing system performance when its function is essential for plant safety. Both the PM and RCM approaches require that system reliability data be updated as more component failures and operation time are acquired. Systems reliability and the likelihood of component failures can be calculated by Bayesian statistical methods, whichmore » can update these data. The DATMAN computer code has been developed at Penn State to simplify the Bayesian analysis by performing tedious calculations needed for RCM reliability analysis. DATMAN reads data for updating, fits a distribution that best fits the data, and calculates component reliability. DATMAN provides a user-friendly interface menu that allows the user to choose from several common prior and posterior distributions, insert new failure data, and visually select the distribution that matches the data most accurately.« less

Effectiveness of the Illinois .08 law : an update with 1999 FARS data

DOT National Transportation Integrated Search

2001-12-01

In December 2000, the National Highway Traffic Safety Administration published a report on the effectiveness of the .08 law implemented by Illinois in July 1997. That report covered data from the Fatality Analysis Reporting System (FARS) through 1998...

Development of an updated tensile neck injury criterion.

PubMed

Parr, Jeffrey C; Miller, Michael E; Schubert Kabban, Christine M; Pellettiere, Joseph A; Perry, Chris E

2014-10-01

Ejection neck safety remains a concern in military aviation with the growing use of helmet mounted displays (HMDs) worn for entire mission durations. The original USAF tensile neck injury criterion proposed by Carter et al. (4) is updated and an injury protection limit for tensile loading is presented to evaluate escape system and HMD safety. An existent tensile neck injury criterion was updated through the addition of newer post mortem human subject (PMHS) tensile loading and injury data and the application of Survival Analysis to account for censoring in this data. The updated risk function was constructed with a combined human subject (N = 208) and PMHS (N = 22) data set. An updated AIS 3+ tensile neck injury criterion is proposed based upon human and PMHS data. This limit is significantly more conservative than the criterion proposed by Carter in 2000, yielding a 5% risk of AIS 3+ injury at a force of 1136 N as compared to a corresponding force of 1559 N. The inclusion of recent PMHS data into the original tensile neck injury criterion results in an injury protection limit that is significantly more conservative, as recent PMHS data is substantially less censored than the PMHS data included in the earlier criterion. The updated tensile risk function developed in this work is consistent with the tensile risk function published by the Federal Aviation Administration used as the basis for their neck injury criterion for side facing aircraft seats.

Space Construction Experiment Definition Study (SCEDS), part 2. Volume 2: Study results

NASA Technical Reports Server (NTRS)

1982-01-01

The Space Construction Experiment (SCE) was defined for integration into the Space Shuttle. This included development of flight assignment data, revision and update of preliminary mission timelines and test plans, analysis of flight safety issues, and definition of ground operations scenarios. New requirements for the flight experiment and changes for a large space antenna feed mask test article were incorporated. The program plan and cost estimates were updated. Revised SCE structural dynamics characteristics were provided for simulation and analysis of experimental tests to define and verify control limits and interactions effects between the SCE and the Orbiter digital automatic pilot.

Assessment of potential doses to workers during postulated accident conditions at the Waste Isolation Pilot Plant

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hoover, M.D.; Farrell, R.F.; Newton, G.J.

1995-12-01

The recent 1995 WIPP Safety Analysis Report (SAR) Update provided detailed analyses of potential radiation doses to members of the public at the site boundary during postulated accident scenarios at the U.S. Department of Energy`s Waste Isolation Pilot Plant (WIPP). The SAR Update addressed the complete spectrum of potential accidents associated with handling and emplacing transuranic waste at WIPP, including damage to waste drums from fires, punctures, drops, and other disruptions. The report focused on the adequacy of the multiple layers of safety practice ({open_quotes}defense-in-depth{close_quotes}) at WIPP, which are designed to (1) reduce the likelihood of accidents and (2) limitmore » the consequences of those accidents. The safeguards which contribute to defense-in-depth at WIPP include a substantial array of inherent design features, engineered controls, and administrative procedures. The SAR Update confirmed that the defense-in-depth at WIPP is adequate to assure the protection of the public and environment. As a supplement to the 1995 SAR Update, we have conducted additional analyses to confirm that these controls will also provide adequate protection to workers at the WIPP. The approaches and results of the worker dose assessment are summarized here. In conformance with the guidance of DOE Standard 3009-94, we emphasize that use of these evaluation guidelines is not intended to imply that these numbers constitute acceptable limits for worker exposures under accident conditions. However, in conjunction with the extensive safety assessment in the 1995 SAR Update, these results indicate that the Carlsbad Area Office strategy for the assessment of hazards and accidents assures the protection of workers, members of the public, and the environment.« less

A SAFE consortium position paper: Update on microbial safety of fresh produce

USDA-ARS?s Scientific Manuscript database

Surveys of fresh produce demonstrate potential to become contaminated with pathogenic microorganisms. The analysis of microbiological risk is generally divided into three categories: Risk Assessment identifies the factors that contribute to a problem; Risk Management identifies ways to solve a probl...

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

Reflecting Secretary O`Leary`s focus on occupational safety and health, the Office of Occupational Safety is pleased to provide you with the latest update to the DOE Interpretations Guide to OSH Standards. This Guide was developed in cooperation with the Occupational Safety and Health Administration, which continued its support during this last revision by facilitating access to the interpretations found on the OSHA Computerized Information System (OCIS). This March 31, 1994 update contains 123 formal interpretation letters written by OSHA. As a result of the unique requests received by the 1-800 Response Line, this update also contains 38 interpretations developed bymore » DOE. This new occupational safety and health information adds still more important guidance to the four volume reference set that you presently have in your possession.« less

NASA's Software Safety Standard

NASA Technical Reports Server (NTRS)

Ramsay, Christopher M.

2007-01-01

NASA relies more and more on software to control, monitor, and verify its safety critical systems, facilities and operations. Since the 1960's there has hardly been a spacecraft launched that does not have a computer on board that will provide command and control services. There have been recent incidents where software has played a role in high-profile mission failures and hazardous incidents. For example, the Mars Orbiter, Mars Polar Lander, the DART (Demonstration of Autonomous Rendezvous Technology), and MER (Mars Exploration Rover) Spirit anomalies were all caused or contributed to by software. The Mission Control Centers for the Shuttle, ISS, and unmanned programs are highly dependant on software for data displays, analysis, and mission planning. Despite this growing dependence on software control and monitoring, there has been little to no consistent application of software safety practices and methodology to NASA's projects with safety critical software. Meanwhile, academia and private industry have been stepping forward with procedures and standards for safety critical systems and software, for example Dr. Nancy Leveson's book Safeware: System Safety and Computers. The NASA Software Safety Standard, originally published in 1997, was widely ignored due to its complexity and poor organization. It also focused on concepts rather than definite procedural requirements organized around a software project lifecycle. Led by NASA Headquarters Office of Safety and Mission Assurance, the NASA Software Safety Standard has recently undergone a significant update. This new standard provides the procedures and guidelines for evaluating a project for safety criticality and then lays out the minimum project lifecycle requirements to assure the software is created, operated, and maintained in the safest possible manner. This update of the standard clearly delineates the minimum set of software safety requirements for a project without detailing the implementation for those requirements. This allows the projects leeway to meet these requirements in many forms that best suit a particular project's needs and safety risk. In other words, it tells the project what to do, not how to do it. This update also incorporated advances in the state of the practice of software safety from academia and private industry. It addresses some of the more common issues now facing software developers in the NASA environment such as the use of Commercial-Off-the-Shelf Software (COTS), Modified OTS (MOTS), Government OTS (GOTS), and reused software. A team from across NASA developed the update and it has had both NASA-wide internal reviews by software engineering, quality, safety, and project management. It has also had expert external review. This presentation and paper will discuss the new NASA Software Safety Standard, its organization, and key features. It will start with a brief discussion of some NASA mission failures and incidents that had software as one of their root causes. It will then give a brief overview of the NASA Software Safety Process. This will include an overview of the key personnel responsibilities and functions that must be performed for safety-critical software.

Updated laser safety & hazard analysis for the ARES laser system based on the 2007 ANSI Z136.1 standard.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Augustoni, Arnold L.

A laser safety and hazard analysis was performed for the temperature stabilized Big Sky Laser Technology (BSLT) laser central to the ARES system based on the 2007 version of the American National Standards Institutes (ANSI) Standard Z136.1, for Safe Use of Lasers and the 2005 version of the ANSI Standard Z136.6, for Safe Use of Lasers Outdoors. The ARES laser system is a Van/Truck based mobile platform, which is used to perform laser interaction experiments and tests at various national test sites.

Preparing for the Update of New Hampshire's Strategic Highway Safety Plan : An RSPCB Peer Exchange

DOT National Transportation Integrated Search

2011-05-01

This report provides a summary of a peer exchange sponsored by the New Hampshire Department of Transportation (NHDOT) that focused on updating New Hampshires Strategic Highway Safety Plan (SHSP) and establishing a Toward Zero Deaths (TZD) initiati...

Evidence Report : 2010 update, diabetes and commercial motor vehicle driver safety : May 27, 2011.

DOT National Transportation Integrated Search

2011-05-27

This report was prepared by MANILA Consulting Group, Inc. under Contract No. GS-10F-0177N; Order No. DTMC75-10-F-00013, entitled Medical Programs Research and Analysis Panels Project, with the Department of Transportations Federal Motor Carrier...

Evidence report : 2010 update, diabetes and commercial motor vehicle driver safety : May 27, 2011.

DOT National Transportation Integrated Search

2011-05-27

This report was prepared by MANILA Consulting Group, Inc. under Contract No. GS-10F-0177N; Order No. DTMC75-10-F-00013, entitled Medical Programs Research and Analysis Panels Project, with the Department of Transportations Federal Motor Carrier...

Analysis of FMCSA's revised civil penalties (1995-2006) : a follow-up study

DOT National Transportation Integrated Search

2009-08-31

This final report updates the results of a July 2004 report that was prepared in response to Section 222(d) of the Motor Carrier Safety Improvement Act of 1999 (MCSIA). Section 222(d) of the Act required the Secretary of Transportation to conduct a s...

10 CFR 72.48 - Changes, tests, and experiments.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 2 2012-01-01 2012-01-01 false Changes, tests, and experiments. 72.48 Section 72.48... Issuance and Conditions of License § 72.48 Changes, tests, and experiments. (a) Definitions for the... times). (7) Tests or experiments not described in the Final Safety Analysis Report (as updated) means...

10 CFR 72.48 - Changes, tests, and experiments.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 2 2013-01-01 2013-01-01 false Changes, tests, and experiments. 72.48 Section 72.48... Issuance and Conditions of License § 72.48 Changes, tests, and experiments. (a) Definitions for the... times). (7) Tests or experiments not described in the Final Safety Analysis Report (as updated) means...

10 CFR 72.48 - Changes, tests, and experiments.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 2 2014-01-01 2014-01-01 false Changes, tests, and experiments. 72.48 Section 72.48... Issuance and Conditions of License § 72.48 Changes, tests, and experiments. (a) Definitions for the... times). (7) Tests or experiments not described in the Final Safety Analysis Report (as updated) means...

Safety impact of engineering treatments on undivided rural roads.

PubMed

Pérez, I

2006-01-01

This article presents an evaluation of the safety impacts of four engineering treatments implemented in the Autonomous Community of Madrid (Spain): highway upgrading; updating and improvement of traffic signing; repainting of pavement markings and pavement resurfacings. This evaluation was carried out using the Empirical Bayes method with a comparison group. The functioning of a methodology to test the significance of the safety impact is described. The results show that highway upgrading has a positive and significant safety impact, while the updating and improvement of traffic signing, the repainting of road markings and pavement resurfacings do not exhibit a significant impact on safety.

Gypcheck environmentally safe viral insecticide for gypsy moth control

Treesearch

Richard Reardon; John Podgwaite; Roger Zerillo

2012-01-01

This handbook is an update of handbook FHTET-2009-01, Gypchek - Bioinsecticide for the Gypsy Moth, printed in July, 2009. This update contains information on virus production, safety evaluations, results of efficacy and deposition evaluations, commercial production, and a copy of the revised registration label, material safety data sheet, and...

Analysis of the academic production in food safety surveillance, 1993-2007.

PubMed

Ribeiro, Vanessa Fernandes; Matté, Glavur Rogerio

2010-12-01

The study aimed to analyze the themes related to the area of food safety surveillance that were approached in scientific research studies from postgraduate programs, with potential in-service application. A total of 337 theses and dissertations submitted to Universidade de São Paulo between 1993 and 2007 was analyzed. The results showed that research developed in universities can be applied to health surveillance, mainly regarding orientation to workers in this area in terms of updated practices.

FY2017 Updates to the SAS4A/SASSYS-1 Safety Analysis Code

DOE Office of Scientific and Technical Information (OSTI.GOV)

Fanning, T. H.

The SAS4A/SASSYS-1 safety analysis software is used to perform deterministic analysis of anticipated events as well as design-basis and beyond-design-basis accidents for advanced fast reactors. It plays a central role in the analysis of U.S. DOE conceptual designs, proposed test and demonstration reactors, and in domestic and international collaborations. This report summarizes the code development activities that have taken place during FY2017. Extensions to the void and cladding reactivity feedback models have been implemented, and Control System capabilities have been improved through a new virtual data acquisition system for plant state variables and an additional Block Signal for a variablemore » lag compensator to represent reactivity feedback for novel shutdown devices. Current code development and maintenance needs are also summarized in three key areas: software quality assurance, modeling improvements, and maintenance of related tools. With ongoing support, SAS4A/SASSYS-1 can continue to fulfill its growing role in fast reactor safety analysis and help solidify DOE’s leadership role in fast reactor safety both domestically and in international collaborations.« less

Updated efficacy analysis including secondary population results for OAK: a randomized phase III study of atezolizumab vs docetaxel in patients with previously treated advanced non-small cell lung cancer.

PubMed

Fehrenbacher, L; von Pawel, J; Park, K; Rittmeyer, A; Gandara, D R; Ponce Aix, S; Han, J-Y; Gadgeel, S M; Hida, T; Cortinovis, D L; Cobo, M; Kowalski, D M; De Marinis, F; Gandhi, M; Danner, B; Matheny, C; Kowanetz, M; He, P; Felizzi, F; Patel, H; Sandler, A; Ballinger, M; Barlesi, F

2018-05-16

The efficacy and safety of atezolizumab vs docetaxel as second- or third-line treatment in patients with advanced non-small cell lung cancer in the primary (n=850; ITT850) and secondary (n=1225; ITT1225) efficacy populations of the randomized phase III OAK study at an updated data cutoff were assessed. Patients received atezolizumab 1200mg or docetaxel 75mg/m 2 intravenously every 3 weeks until loss of clinical benefit or disease progression, respectively. The primary endpoint was overall survival (OS) in the intention-to-treat (ITT) population and programmed death-ligand 1 (PD-L1)-expressing subgroup. A sensitivity analysis was conducted to evaluate the impact of subsequent immunotherapy use in the docetaxel arm on observed survival benefit with atezolizumab. Atezolizumab demonstrated OS benefit vs docetaxel in the updated ITT850 (hazard ratio [HR] 0.75; 95% CI 0.64-0.89; P = .0006) and the ITT1225 (HR 0.80; 0.70-0.92; P = .0012) after minimum follow-up of 26 and 21 months, respectively. Improved survival with atezolizumab was observed across PD-L1 and histology subgroups. The relative OS benefit with atezolizumab was slightly greater in the immunotherapy sensitivity analysis in the ITT850 (HR 0.69) and ITT1225 (HR 0.74) compared to conventional OS estimation. Fewer patients receiving atezolizumab experienced grade 3/4 treatment-related adverse events (14.9%) than those receiving docetaxel (42.4%); no grade 5 events related to atezolizumab were observed. The updated ITT850 and initial ITT1225 analyses were consistent with the primary efficacy analysis demonstrating survival benefit with atezolizumab vs docetaxel. Atezolizumab continued to demonstrate a favorable safety profile after longer treatment exposure and follow-up. Copyright © 2018. Published by Elsevier Inc.

ballast water « Coast Guard Maritime Commons

Science.gov Websites

updates to Marine Safety Center's ballast water management system website The Marine Safety Center recently updated two tools posted to its ballast water management system website to assist industry when completing the ballast water management system type approval process, or when accessing letters of intent. 12

Commercial Vessel Compliance « Coast Guard Maritime Commons

Science.gov Websites

updates to Marine Safety Center's ballast water management system website The Marine Safety Center recently updated two tools posted to its ballast water management system website to assist industry when completing the ballast water management system type approval process, or when accessing letters of intent. 5

Notification: FY 2017 Update of Proposed Key Management Challenges and Internal Control Weaknesses Confronting the U.S. Chemical Safety and Hazard Investigation Board

EPA Pesticide Factsheets

Jan 5, 2017. The EPA OIG is beginning work to update for fiscal year 2017 its list of proposed key management challenges and internal control weaknesses confronting the U.S. Chemical Safety and Hazard Investigation Board (CSB).

76 FR 60962 - Noise Exposure Map Update for Buffalo Niagara International Airport, Buffalo, NY

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-30

... International Airport, under the provisions of 49 U.S.C. 47501 et seq. (Aviation Safety and Noise Abatement Act...''), effective September 20, 2011. Under 49 U.S.C. section 47503 of the Aviation Safety and Noise Abatement Act... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Noise Exposure Map Update for Buffalo...

49 CFR 194.121 - Response plan review and update procedures.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 3 2011-10-01 2011-10-01 false Response plan review and update procedures. 194... SAFETY RESPONSE PLANS FOR ONSHORE OIL PIPELINES Response Plans § 194.121 Response plan review and update procedures. (a) Each operator shall update its response plan to address new or different operating conditions...

49 CFR 194.121 - Response plan review and update procedures.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 3 2013-10-01 2013-10-01 false Response plan review and update procedures. 194... SAFETY RESPONSE PLANS FOR ONSHORE OIL PIPELINES Response Plans § 194.121 Response plan review and update procedures. (a) Each operator shall update its response plan to address new or different operating conditions...

49 CFR 194.121 - Response plan review and update procedures.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 3 2014-10-01 2014-10-01 false Response plan review and update procedures. 194... SAFETY RESPONSE PLANS FOR ONSHORE OIL PIPELINES Response Plans § 194.121 Response plan review and update procedures. (a) Each operator shall update its response plan to address new or different operating conditions...

49 CFR 194.121 - Response plan review and update procedures.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 3 2012-10-01 2012-10-01 false Response plan review and update procedures. 194... SAFETY RESPONSE PLANS FOR ONSHORE OIL PIPELINES Response Plans § 194.121 Response plan review and update procedures. (a) Each operator shall update its response plan to address new or different operating conditions...

49 CFR 194.121 - Response plan review and update procedures.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 3 2010-10-01 2010-10-01 false Response plan review and update procedures. 194... SAFETY RESPONSE PLANS FOR ONSHORE OIL PIPELINES Response Plans § 194.121 Response plan review and update procedures. (a) Each operator shall update its response plan to address new or different operating conditions...

An Analysis of the Relationship between Casualty Risk Per Crash and Vehicle Mass and Footprint for Model Year 2000-2007 Light-Duty Vehicles

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wenzel, Tom

2012-08-01

NHTSA recently completed a logistic regression analysis (Kahane 2012) updating its 2003 and 2010 studies of the relationship between vehicle mass and US fatality risk per vehicle mile traveled (VMT). The new study updates the previous analyses in several ways: updated FARS data for 2002 to 2008 involving MY00 to MY07 vehicles are used; induced exposure data from police reported crashes in several additional states are added; a new vehicle category for car-based crossover utility vehicles (CUVs) and minivans is created; crashes with other light-duty vehicles are divided into two groups based on the crash partner vehicle’s weight, and amore » category for all other fatal crashes is added; and new control variables for new safety technologies and designs, such as electronic stability controls (ESC), side airbags, and methods to meet voluntary agreement to improve light truck compatibility with cars, are included.« less

Monitoring product safety in the postmarketing environment.

PubMed

Sharrar, Robert G; Dieck, Gretchen S

2013-10-01

The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include a review of individual reports, a review of a frequency distribution of a list of the adverse experiences, the development and analysis of a case series, and various ways of examining the database for signals of disproportionality, which may suggest a possible association. Regulatory agencies monitor product safety through a variety of mechanisms including signal detection of the adverse experience safety reports in databases and by requiring and monitoring risk management plans, periodic safety update reports and postauthorization safety studies. The United States Food and Drug Administration is working with public, academic and private entities to develop methods for using large electronic databases to actively monitor product safety. Important identified risks will have to be evaluated through observational studies and registries.

Accident analysis and control options in support of the sludge water system safety analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

HEY, B.E.

A hazards analysis was initiated for the SWS in July 2001 (SNF-8626, K Basin Sludge and Water System Preliminary Hazard Analysis) and updated in December 2001 (SNF-10020 Rev. 0, Hazard Evaluation for KE Sludge and Water System - Project A16) based on conceptual design information for the Sludge Retrieval System (SRS) and 60% design information for the cask and container. SNF-10020 was again revised in September 2002 to incorporate new hazards identified from final design information and from a What-if/Checklist evaluation of operational steps. The process hazards, controls, and qualitative consequence and frequency estimates taken from these efforts have beenmore » incorporated into Revision 5 of HNF-3960, K Basins Hazards Analysis. The hazards identification process documented in the above referenced reports utilized standard industrial safety techniques (AIChE 1992, Guidelines for Hazard Evaluation Procedures) to systematically guide several interdisciplinary teams through the system using a pre-established set of process parameters (e.g., flow, temperature, pressure) and guide words (e.g., high, low, more, less). The teams generally included representation from the U.S. Department of Energy (DOE), K Basins Nuclear Safety, T Plant Nuclear Safety, K Basin Industrial Safety, fire protection, project engineering, operations, and facility engineering.« less

78 FR 26810 - Adequacy of Design Features and Functional Capabilities Identified and Described for Withstanding...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-08

.... ACTION: Standard review plan section; issuance. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing a new section of NUREG-0800, ``Standard Review Plan for the Review of Safety Analysis Reports for... impacts.'' DATES: The effective date of this Standard Review Plan (SRP) update is June 7, 2013. ADDRESSES...

Six Tips for College Health and Safety

MedlinePlus

... Emergency Preparedness & Response Environmental Health Healthy Living Injury, Violence & Safety Life Stages & Populations Travelers’ Health Workplace Safety & Health Features Media Sign up for Features Get Email Updates To ...

Engineering and Safety Partnership Enhances Safety of the Space Shuttle Program (SSP)

NASA Technical Reports Server (NTRS)

Duarte, Alberto

2007-01-01

Project Management must use the risk assessment documents (RADs) as tools to support their decision making process. Therefore, these documents have to be initiated, developed, and evolved parallel to the life of the project. Technical preparation and safety compliance of these documents require a great deal of resources. Updating these documents after-the-fact not only requires substantial increase in resources - Project Cost -, but this task is also not useful and perhaps an unnecessary expense. Hazard Reports (HRs), Failure Modes and Effects Analysis (FMEAs), Critical Item Lists (CILs), Risk Management process are, among others, within this category. A positive action resulting from a strong partnership between interested parties is one way to get these documents and related processes and requirements, released and updated in useful time. The Space Shuttle Program (SSP) at the Marshall Space Flight Center has implemented a process which is having positive results and gaining acceptance within the Agency. A hybrid Panel, with equal interest and responsibilities for the two larger organizations, Safety and Engineering, is the focal point of this process. Called the Marshall Safety and Engineering Review Panel (MSERP), its charter (Space Shuttle Program Directive 110 F, April 15, 2005), and its Operating Control Plan emphasizes the technical and safety responsibilities over the program risk documents: HRs; FMEA/CILs; Engineering Changes; anomalies/problem resolutions and corrective action implementations, and trend analysis. The MSERP has undertaken its responsibilities with objectivity, assertiveness, dedication, has operated with focus, and has shown significant results and promising perspectives. The MSERP has been deeply involved in propulsion systems and integration, real time technical issues and other relevant reviews, since its conception. These activities have transformed the propulsion MSERP in a truly participative and value added panel, making a difference for the safety of the Space Shuttle Vehicle, its crew, and personnel. Because of the MSERP's valuable contribution to the assessment of safety risk for the SSP, this paper also proposes an enhanced Panel concept that takes this successful partnership concept to a higher level of 'true partnership'. The proposed panel is aimed to be responsible for the review and assessment of all risk relative to Safety for new and future aerospace and related programs.

Thyroid Radiofrequency Ablation: Updates on Innovative Devices and Techniques

PubMed Central

Park, Hye Sun; Park, Auh Whan; Chung, Sae Rom; Choi, Young Jun; Lee, Jeong Hyun

2017-01-01

Radiofrequency ablation (RFA) is a well-known, effective, and safe method for treating benign thyroid nodules and recurrent thyroid cancers. Thyroid-dedicated devices and basic techniques for thyroid RFA were introduced by the Korean Society of Thyroid Radiology (KSThR) in 2012. Thyroid RFA has now been adopted worldwide, with subsequent advances in devices and techniques. To optimize the treatment efficacy and patient safety, understanding the basic and advanced RFA techniques and selecting the optimal treatment strategy are critical. The goal of this review is to therefore provide updates and analysis of current devices and advanced techniques for RFA treatment of benign thyroid nodules and recurrent thyroid cancers. PMID:28670156

Red Cross Swimming Update.

ERIC Educational Resources Information Center

Vlasich, Cynthia

1989-01-01

Six new aquatic courses, developed by the Red Cross, are described. They are: Infant and Preschool Aquatics, Longfellow's Whale Tales (classroom water safety lessons for K-Six), Basic Water Safety, Emergency Water Safety, Lifeguard Training, and Safety Training for Swim Coaches. (IAH)

Final safety analysis report for the Galileo Mission: Volume 1, Reference design document

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

The Galileo mission uses nuclear power sources called Radioisotope Thermoelectric Generators (RTGs) to provide the spacecraft's primary electrical power. Because these generators contain nuclear material, a Safety Analysis Report (SAR) is required. A preliminary SAR and an updated SAR were previously issued that provided an evolving status report on the safety analysis. As a result of the Challenger accident, the launch dates for both Galileo and Ulysses missions were later rescheduled for November 1989 and October 1990, respectively. The decision was made by agreement between the DOE and the NASA to have a revised safety evaluation and report (FSAR) preparedmore » on the basis of these revised vehicle accidents and environments. The results of this latest revised safety evaluation are presented in this document (Galileo FSAR). Volume I, this document, provides the background design information required to understand the analyses presented in Volumes II and III. It contains descriptions of the RTGs, the Galileo spacecraft, the Space Shuttle, the Inertial Upper Stage (IUS), the trajectory and flight characteristics including flight contingency modes, and the launch site. There are two appendices in Volume I which provide detailed material properties for the RTG.« less

Patient Safety: Ten Things You Can Do to Be a Safe Patient

MedlinePlus

... Emergency Preparedness & Response Environmental Health Healthy Living Injury, Violence & Safety Life Stages & Populations Travelers’ Health Workplace Safety & Health Features Media Sign up for Features Get Email Updates To ...

An observational survey of safety belt and child safety seat use in Virginia : the 1989 update.

DOT National Transportation Integrated Search

1991-01-01

The report has been prepared in response to a request from the Transportation Safety Administration of the Department of Motor Vehicles for data concerning the use of safety belts and child safety seats by the occupants of vehicles bearing Virginia l...

An observational survey of safety belt and child safety seat use in Virginia : final report : the 1990 update.

DOT National Transportation Integrated Search

1992-01-01

This report was prepared in response to a request from the Transportation Safety Administration of the Virginia Department ofMotor Vehicles for data concerning the use of safety belts and child safety seats by the occupants of vehicles bearing Virgin...

Assuring Safety in Bus Transportation--Update on Federal Legislation.

ERIC Educational Resources Information Center

Craft, Nick

2003-01-01

Discusses the growing use of vans for transportation by child care centers and increasing concerns about van safety. Presents information on relevant federal legislation related to motor vehicle safety and the safety standards of the National Highway Traffic Safety Administration. Recommends that child care programs replace retiring vans with…

Training Presentation for NASA Civil Helicopter Safety Website

NASA Technical Reports Server (NTRS)

Iseler, Laura

2002-01-01

NASA civil helicopter safety News & Updates include the following: Mar. 2002. The Air Medical Operations Survey has been completed! Check it out! Also accessible via the Mission pages under Air Medical Mission. Air Medical and Law Enforcement Mission pages have been added. They are accessible via the Mission pages. The Public Use, Personal, Offshore, Law Enforcement, External Load, Business and Gyro accident pages (accessable via the Mission page) have been updated. Feb. 2002. A Words of Wisdom section has been added. You can access it by clicking the Library button. A link to a Corporate Accident Response Plan has been added to the Accident page. The AMs, Aerial Application and Instruction accident pages (accessable via the Mission page) have been updated. Jan. 2002. A new searchable safety article database has been added. You can access it by clicking the Library button. The 2001 accident summaries have been updated and the statistics have been compiled - check it out by clicking the accident tab to the left. Dec. 2001. Please read the FAA Administrator's memo regarding the latest FBI warning. 3ee the FAA column - Fall 2001 Read it now!

Thalassemia

MedlinePlus

... Emergency Preparedness & Response Environmental Health Healthy Living Injury, Violence & Safety Life Stages & Populations Travelers’ Health Workplace Safety & Health Features Media Sign up for Features Get Email Updates To ...

Selecting Strategies to Reduce High-Risk Unsafe Work Behaviors Using the Safety Behavior Sampling Technique and Bayesian Network Analysis.

PubMed

Ghasemi, Fakhradin; Kalatpour, Omid; Moghimbeigi, Abbas; Mohammadfam, Iraj

2017-03-04

High-risk unsafe behaviors (HRUBs) have been known as the main cause of occupational accidents. Considering the financial and societal costs of accidents and the limitations of available resources, there is an urgent need for managing unsafe behaviors at workplaces. The aim of the present study was to find strategies for decreasing the rate of HRUBs using an integrated approach of safety behavior sampling technique and Bayesian networks analysis. A cross-sectional study. The Bayesian network was constructed using a focus group approach. The required data was collected using the safety behavior sampling, and the parameters of the network were estimated using Expectation-Maximization algorithm. Using sensitivity analysis and belief updating, it was determined that which factors had the highest influences on unsafe behavior. Based on BN analyses, safety training was the most important factor influencing employees' behavior at the workplace. High quality safety training courses can reduce the rate of HRUBs about 10%. Moreover, the rate of HRUBs increased by decreasing the age of employees. The rate of HRUBs was higher in the afternoon and last days of a week. Among the investigated variables, training was the most important factor affecting safety behavior of employees. By holding high quality safety training courses, companies would be able to reduce the rate of HRUBs significantly.

Updating Human Factors Engineering Guidelines for Conducting Safety Reviews of Nuclear Power Plants

DOE Office of Scientific and Technical Information (OSTI.GOV)

O, J.M.; Higgins, J.; Stephen Fleger - NRC

The U.S. Nuclear Regulatory Commission (NRC) reviews the human factors engineering (HFE) programs of applicants for nuclear power plant construction permits, operating licenses, standard design certifications, and combined operating licenses. The purpose of these safety reviews is to help ensure that personnel performance and reliability are appropriately supported. Detailed design review procedures and guidance for the evaluations is provided in three key documents: the Standard Review Plan (NUREG-0800), the HFE Program Review Model (NUREG-0711), and the Human-System Interface Design Review Guidelines (NUREG-0700). These documents were last revised in 2007, 2004 and 2002, respectively. The NRC is committed to the periodicmore » update and improvement of the guidance to ensure that it remains a state-of-the-art design evaluation tool. To this end, the NRC is updating its guidance to stay current with recent research on human performance, advances in HFE methods and tools, and new technology being employed in plant and control room design. This paper describes the role of HFE guidelines in the safety review process and the content of the key HFE guidelines used. Then we will present the methodology used to develop HFE guidance and update these documents, and describe the current status of the update program.« less

Stop Ticks

MedlinePlus

... Emergency Preparedness & Response Environmental Health Healthy Living Injury, Violence & Safety Life Stages & Populations Travelers’ Health Workplace Safety & Health Features Media Sign up for Features Get Email Updates To ...

Prevent Shingles

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Preventing Suicide

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10 CFR 50.71 - Maintenance of records, making of reports.

Code of Federal Regulations, 2012 CFR

2012-01-01

... submittal of the original FSAR, or as appropriate, the last update to the FSAR under this section. The..., shall update periodically, as provided in paragraphs (e) (3) and (4) of this section, the final safety... located within the update to the FSAR. 1 Effects of changes includes appropriate revisions of descriptions...

10 CFR 50.71 - Maintenance of records, making of reports.

Code of Federal Regulations, 2011 CFR

2011-01-01

... submittal of the original FSAR, or as appropriate, the last update to the FSAR under this section. The..., shall update periodically, as provided in paragraphs (e) (3) and (4) of this section, the final safety... located within the update to the FSAR. 1 Effects of changes includes appropriate revisions of descriptions...

10 CFR 50.71 - Maintenance of records, making of reports.

Code of Federal Regulations, 2014 CFR

2014-01-01

... submittal of the original FSAR, or as appropriate, the last update to the FSAR under this section. The..., shall update periodically, as provided in paragraphs (e) (3) and (4) of this section, the final safety... located within the update to the FSAR. 1 Effects of changes includes appropriate revisions of descriptions...

10 CFR 50.71 - Maintenance of records, making of reports.

Code of Federal Regulations, 2013 CFR

2013-01-01

... submittal of the original FSAR, or as appropriate, the last update to the FSAR under this section. The..., shall update periodically, as provided in paragraphs (e) (3) and (4) of this section, the final safety... located within the update to the FSAR. 1 Effects of changes includes appropriate revisions of descriptions...

International Space Station (ISS) Plasma Contactor Unit (PCU) Utilization Plan Assessment Update

NASA Technical Reports Server (NTRS)

Hernandez-Pellerano, Amri; Iannello, Christopher J.; Wollack, Edward J.; Wright, Kenneth H.; Garrett, Henry B.; Ging, Andrew T.; Katz, Ira; Keith, R. Lloyd; Minow, Joseph I.; Willis, Emily M.;

Capitalizing on Federal Agencies' Intentions To Protect Youth Working in Agriculture.

PubMed

Murphy, Dennis J

2017-01-01

Nearly 750,000 youth work on farms across the United States. The U.S. Department of Labor's (U.S. DOL) Fair Labor Standards Act (FLSA) Hazardous Occupations Orders for Agriculture (HOOA) applies to approximately 37% of these youth. The HOOA regulations had not been updated since their inception in the late 1960s and the early 1970s. An attempt by U.S. DOL to update the regulations in 2011 was met with fierce opposition by the agricultural community, and the proposed updated regulations were withdrawn. One impactful outcome of these two events was a rededication by USDA and the farm community to address agricultural youth farm safety through education rather than through regulation. An agriculturally based National Steering Committee has developed consensus Belief Statements and Guiding Principles to proactively influence agricultural youth safety. In this case, USDA was clearly a 'sphere of influence' for youth agricultural safety.

Alcohol highway safety : problem update

DOT National Transportation Integrated Search

1998-04-01

Author's abstract: This document examines new literature and data on selected alcohol-crash targets or problems that have become available since the November 1989 State of Knowledge review. Specifically, this update addresses research since the 1989 ...

Mitigating Motion Base Safety Issues: The NASA LaRC CMF Implementation

NASA Technical Reports Server (NTRS)

Bryant, Richard B., Jr.; Grupton, Lawrence E.; Martinez, Debbie; Carrelli, David J.

2005-01-01

The NASA Langley Research Center (LaRC), Cockpit Motion Facility (CMF) motion base design has taken advantage of inherent hydraulic characteristics to implement safety features using hardware solutions only. Motion system safety has always been a concern and its implementation is addressed differently by each organization. Some approaches rely heavily on software safety features. Software which performs safety functions is subject to more scrutiny making its approval, modification, and development time consuming and expensive. The NASA LaRC's CMF motion system is used for research and, as such, requires that the software be updated or modified frequently. The CMF's customers need the ability to update the simulation software frequently without the associated cost incurred with safety critical software. This paper describes the CMF engineering team's approach to achieving motion base safety by designing and implementing all safety features in hardware, resulting in applications software (including motion cueing and actuator dynamic control) being completely independent of the safety devices. This allows the CMF safety systems to remain intact and unaffected by frequent research system modifications.

Wash Your Hands

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Avoid Mosquito Bites

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Oysters and Vibriosis

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Technical books and monographs: 1978 catalog

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

This publication is a bibliography of books and monographs sponsored by the U. S. Department of Energy (DOE) and by the earlier organizations that were brought together to form DOE. In general, information for each published book, and for each book in press when known, includes title; author and author affiliation; publisher and publication date; page count; size of book; price; availability information if the book is not available from the publisher; Library of Congress card number (LC), with CIP to indicate books that have cataloging information in the publication; International Standard Book Number (ISBN); a brief descriptive statement concerningmore » the book; and for the more recent books a list or a description of the contents. The books and monographs are grouped under thirteen subject categories. At the end of each subject category are separate sections listing recent published symposiums and bibliographies that received support from DOE or one of the earlier organizations. Also, at the end of the catalog are described the following DOE publications: Energy Research Abstracts, Energy Abstracts for Policy Analysis, Energy Conservation Update, Fossil Energy Update, F usion Energy Update, Geothermal Energy Update, Solar Energy Update, Nuclear Safety, and Power Reactor Docket Information.« less

Technical books and monographs. 1979 catalog

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

This publication is a bibliography of books and monographs sponsored by the U.S. Department of Energy (DOE) and by the earlier organizations that were brought together to form DOE. In general, information for each published book, and for each book in press when known, includes title, author, and author affiliation, publisher and publication date, page count, size of book, price, availability information if the book is not available from the publisher, Library of Congress card number (LC) (with CIP to indicate books that have cataloging information in the publication), International Standard Book Number (ISBN), a brief descriptive statement concerning themore » book, and (for the more recent books) a list or a description of the contents. The books and monographs are grouped under thirteen subject categories. At the end of each subject category are separate sections listing recently published symposium proceedings and bibliographies that received support from DOE or one of the earlier organizations. Also, at the end of the catalog are described the following DOE publications: Energy Research Abstracts, Energy Abstracts for Policy Analysis, Energy Conservation Update, Fossil Energy Update, Fusion Energy Update, Geothermal Energy Update, Solar Energy Update, and Nuclear Safety.« less

77 FR 2126 - Pipeline Safety: Implementation of the National Registry of Pipeline and Liquefied Natural Gas...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-13

... Natural Gas Operators AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. ACTION... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No...: ``Pipeline Safety: Updates to Pipeline and Liquefied Natural Gas Reporting Requirements.'' The final rule...

Chicken and Food Poisoning

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Autism: Why Act Early?

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Medication Use during Pregnancy

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Learn About Cronobacter Infection

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Bleeding Disorders in Women

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Pregnant? Don't Smoke!

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Home Canning and Botulism

MedlinePlus

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75 FR 13807 - Pipeline Safety: Information Collection Activities

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-23

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No... of Transportation, Pipeline and Hazardous Materials Safety Administration, 1200 New Jersey Avenue, SE...: Updates to Pipeline and Liquefied Natural Gas Reporting Requirements (One Rule). The Notice of Proposed...

Updating RoadHAT : collision diagram builder and HSM elements.

DOT National Transportation Integrated Search

2016-01-01

In order to minimize the losses resulting from traffic crashes, Indiana developed its road safety management methods before the Highway Safety Manual : and the SafetyAnalyst became available. The considerable cost of replacing the Indiana current pra...

2008 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

Lamoreaux, Richard W.

2008-01-01

Welcome to the 2008 edition of the NASA Range Safety Annual Report. Funded by NASA Headquarters, this report provides a NASA Range Safety overview for current and potential range users. This year, along with full length articles concerning various subject areas, we have provided updates to standard subjects with links back to the 2007 original article. Additionally, we present summaries from the various NASA Range Safety Program activities that took place throughout the year, as well as information on several special projects that may have a profound impact on the way we will do business in the future. The sections include a program overview and 2008 highlights of Range Safety Training; Range Safety Policy; Independent Assessments and Common Risk Analysis Tools Development; Support to Program Operations at all ranges conducting NASA launch operations; a continuing overview of emerging Range Safety-related technologies; Special Interests Items that include recent changes in the ELV Payload Safety Program and the VAS explosive siting study; and status reports from all of the NASA Centers that have Range Safety responsibilities. As is the case each year, contributors to this report are too numerous to mention, but we thank individuals from the NASA Centers, the Department of Defense, and civilian organizations for their contributions. We have made a great effort to include the most current information available. We recommend that this report be used only for guidance and that the validity and accuracy of all articles be verified for updates. This is the third year we have utilized this web-based format for the annual report. We continually receive positive feedback on the web-based edition, and we hope you enjoy this year's product as well. It has been a very busy and productive year on many fronts as you will note as you review this report. Thank you to everyone who contributed to make this year a successful one, and I look forward to working with all of you in the years to come.

77 FR 16471 - Pipeline Safety: Implementation of the National Registry of Pipeline and Liquefied Natural Gas...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-21

... Registry of Pipeline and Liquefied Natural Gas Operators AGENCY: Pipeline and Hazardous Materials Safety... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Parts... Register (75 FR 72878) titled: ``Pipeline Safety: Updates to Pipeline and Liquefied Natural Gas Reporting...

Lupus among Asians and Hispanics

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Prevent the Spread of Norovirus

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Are You Getting Enough Sleep?

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Take Care with Pet Reptiles

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Hand, Foot and Mouth Disease

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Carbon Monoxide (CO) Poisoning Prevention

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Helping Children with Congenital CMV

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Need yellow fever vaccine? Plan ahead

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Drowsy Driving: Asleep at the Wheel

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Prevent Type 2 Diabetes in Kids

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Help Protect Babies from Whooping Cough

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Test Your Knowledge of Spina Bifida

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Protect Your Child from Rotavirus Disease

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Lifting Safety: Tips To Help Prevent Back Injuries

MedlinePlus

... injury from lifting? How can I improve my environment to reduce my risk of back injuries? Resources National Safety Council, Lift and Carry U.S. Department of Labor: Occupational Safety and Health Administration, Heavy Lifting Last Updated: March 15, 2017 ...

Safety belt and motorcycle helmet use in Virginia : the Summer 2003 update.

DOT National Transportation Integrated Search

2004-01-01

The Virginia Transportation Research Council has been collecting safety belt use data in Virginia since 1974. In 1992, the National Highway Traffic Safety Administration (NHTSA) published the final guidelines for conducting surveys of belt and helmet...

Safety belt and motorcycle helmet use in Virginia : the Summer 2005 update.

DOT National Transportation Integrated Search

2005-01-01

The Virginia Transportation Research Council has been collecting safety belt use data in Virginia since 1974. In 1992, the National Highway Traffic Safety Administration ( NHTSA) published the final guidelines for conducting surveys of belt and helme...

Safety belt and motorcycle helmet use in Virginia : the Summer 2007 update.

DOT National Transportation Integrated Search

2007-01-01

The Virginia Transportation Research Council has been collecting safety belt use data in Virginia since 1974. In 1992, the National Highway Traffic Safety Administration (NHTSA) published the final guidelines for conducting surveys of belt and helmet...

Safety belt and motorcycle helmet use in Virginia : the Summer 2004 update.

DOT National Transportation Integrated Search

2004-01-01

The Virginia Transportation Research Council has been collecting safety belt use data in Virginia since 1974. In 1992, the National Highway Traffic Safety Administration (NHTSA) published the final guidelines for conducting surveys of belt and helmet...

Safety belt and motorcycle helmet use in Virginia : the Summer 2006 update.

DOT National Transportation Integrated Search

2006-01-01

The Virginia Transportation Research Council has been collecting safety belt use data in Virginia since 1974. In 1992, the National Highway Traffic Safety Administration (NHTSA) published the final guidelines for conducting surveys of belt and helmet...

NHTSA's behavioral safety research: updated, annotated bibliography, 1985-2013 : traffic tech.

DOT National Transportation Integrated Search

2014-01-01

Through many name changes, from the Office of Program : Development and Evaluation, the Office of Research and : Evaluation, to the current Office of Behavioral Safety Research, : our focus has remained on improving the safety of drivers, : occupants...

Next generation safety performance monitoring at signalized intersections using connected vehicle technology.

DOT National Transportation Integrated Search

2014-08-01

Crash-based safety evaluation is often hampered by randomness, lack of timeliness, and rarity of crash : occurrences. This is particularly the case for technology-driven safety improvement projects that are : frequently updated or replaced by newer o...

Updating Rhode Island’s strategic highway safety plan (SHSP).

DOT National Transportation Integrated Search

2012-05-01

This report summarizes the peer exchange sponsored by the Rhode Island Department of Transportation (RIDOT) that focused on Rhode Islands SHSP update. Rhode Islands goals for the peer exchange included learning from other States experiences ...

Applying the School Health Index to a nationally representative sample of schools: update for 2006.

PubMed

Brener, Nancy D; Pejavara, Anu; McManus, Tim

2011-02-01

The School Health Index (SHI) is a tool designed to help schools assess the extent to which they are implementing practices included in the research-based guidelines and strategies for school health and safety programs developed by the Centers for Disease Control and Prevention (CDC). CDC previously analyzed data from the 2000 School Health Policies and Programs Study (SHPPS) to determine the percentage of US schools meeting the recommendations in the SHI. A new edition of the SHI (2005) and the availability of 2006 SHPPS data made it necessary to update and repeat the analysis. SHPPS 2006 data were collected through computer-assisted personal interviews with faculty and staff in a nationally representative sample of schools. The data were then matched to SHI items to calculate the percentage of schools meeting the recommendations in 4 areas: school health and safety policies and environment, health education, physical education and other physical activity programs, and nutrition services. In accordance with the earlier findings, the present analysis indicated that schools nationwide were focusing their efforts on a few policies and programs rather than addressing the entire set of recommendations in the SHI. The percentage of items related to nutrition that schools met remained high, and an increase occurred in the percentage of items that schools met related to school health and safety policies and environment. More work needs to be done to assist schools in implementing school health policies and practices; this analysis helps identify specific areas where improvement is needed. © Published 2011. This article is a US Government work and is in the public domain in the USA.

Pneumonia Can Be Prevented -- Vaccines Can Help

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Protect Your Baby from Group B Strep!

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Don't Let Glaucoma Steal Your Sight!

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Rubella: Make Sure Your Child Gets Vaccinated

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Worried Your Sore Throat May Be Strep?

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Scarlet Fever: A Group A Streptococcal Infection

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Tips to Prevent Illness from Clostridium Perfringens

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Updated Lightning Safety Recommendations.

ERIC Educational Resources Information Center

Vavrek, R. James; Holle, Ronald L.; Lopez, Raul E.

1999-01-01

Summarizes the recommendations of the Lightning Safety Group (LSG), which was first convened during the 1998 American Meteorological Society Conference. Findings outline appropriate actions under various circumstances when lightning threatens. (WRM)

New and incremental FDA black box warnings from 2008 to 2015.

PubMed

Solotke, Michael T; Dhruva, Sanket S; Downing, Nicholas S; Shah, Nilay D; Ross, Joseph S

2018-02-01

The boxed warning (also known as 'black box warning [BBW]') is one of the strongest drug safety actions that the U.S. Food & Drug Administration (FDA) can implement, and often warns of serious risks. The objective of this study was to comprehensively characterize BBWs issued for drugs after FDA approval. We identified all post-marketing BBWs from January 2008 through June 2015 listed on FDA's MedWatch and Drug Safety Communications websites. We used each drug's prescribing information to classify its BBW as new, major update to a preexisting BBW, or minor update. We then characterized these BBWs with respect to pre-specified BBW-specific and drug-specific features. There were 111 BBWs issued to drugs on the US market, of which 29% (n = 32) were new BBWs, 32% (n = 35) were major updates, and 40% (n = 44) were minor updates. New BBWs and major updates were most commonly issued for death (51%) and cardiovascular risk (27%). The new BBWs and major updates impacted 200 drug formulations over the study period, of which 64% were expected to be used chronically and 58% had available alternatives without a BBW. New BBWs and incremental updates to existing BBWs are frequently added to drug labels after regulatory approval.

Safety belt and motorcycle helmet use in Virginia : the Summer 2008 update.

DOT National Transportation Integrated Search

2008-01-01

This survey was conducted at the request of the Virginia Department of Motor Vehicles to track the effectiveness of programmatic efforts carried out to increase safety belt usage in Virginia. The official Virginia safety belt use survey is conducted ...

Nurses' Perceived Skills and Attitudes About Updated Safety Concepts: Impact on Medication Administration Errors and Practices.

PubMed

Armstrong, Gail E; Dietrich, Mary; Norman, Linda; Barnsteiner, Jane; Mion, Lorraine

Approximately a quarter of medication errors in the hospital occur at the administration phase, which is solely under the purview of the bedside nurse. The purpose of this study was to assess bedside nurses' perceived skills and attitudes about updated safety concepts and examine their impact on medication administration errors and adherence to safe medication administration practices. Findings support the premise that medication administration errors result from an interplay among system-, unit-, and nurse-level factors.

Environmental Regulatory Update Table, January/February 1995

DOE Office of Scientific and Technical Information (OSTI.GOV)

Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.

1995-03-01

The Environmental Regulatory Update Table provides information on regulatory initiatives impacting environmental, health, and safety management responsibilities. the table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Be Food Safe: Protect Yourself from Food Poisoning

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Measles: Make Sure Your Child Is Fully Immunized

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Prepare for Diabetes Care in Heat and Emergencies

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Don't Let Measles Be Your Travel Souvenir

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76 FR 17808 - Final Vehicle Safety Rulemaking and Research Priority Plan 2011-2013

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-31

... [Docket No. NHTSA-2009-0108] Final Vehicle Safety Rulemaking and Research Priority Plan 2011- 2013 AGENCY... availability. SUMMARY: This document announces the availability of the Final NHTSA Vehicle Safety and Fuel.... This Priority Plan is an update to the Final Vehicle Safety Rulemaking and Research Priority Plan 2009...

Criticality Safety Evaluation of Standard Criticality Safety Requirements #1-520 g Operations in PF-4

DOE Office of Scientific and Technical Information (OSTI.GOV)

Yamanaka, Alan Joseph Jr.

Guidance has been requested from the Nuclear Criticality Safety Division (NCSD) regarding processes that involve 520 grams of fissionable material or less. This Level-3 evaluation was conducted and documented in accordance with NCS-AP-004 (Ref. 1), formerly NCS-GUIDE-01. This evaluation is being written as a generic evaluation for all operations that will be able to operate using a 520-gram mass limit. Implementation for specific operations will be performed using a Level 1 CSED, which will confirm and document that this CSED can be used for the specific operation as discussed in NCS-MEMO-17-007 (Ref. 2). This Level 3 CSED updates and supersedesmore » the analysis performed in NCS-TECH-14-014 (Ref. 3).« less

A Smartphone-Based Driver Safety Monitoring System Using Data Fusion

PubMed Central

Lee, Boon-Giin; Chung, Wan-Young

2012-01-01

This paper proposes a method for monitoring driver safety levels using a data fusion approach based on several discrete data types: eye features, bio-signal variation, in-vehicle temperature, and vehicle speed. The driver safety monitoring system was developed in practice in the form of an application for an Android-based smartphone device, where measuring safety-related data requires no extra monetary expenditure or equipment. Moreover, the system provides high resolution and flexibility. The safety monitoring process involves the fusion of attributes gathered from different sensors, including video, electrocardiography, photoplethysmography, temperature, and a three-axis accelerometer, that are assigned as input variables to an inference analysis framework. A Fuzzy Bayesian framework is designed to indicate the driver’s capability level and is updated continuously in real-time. The sensory data are transmitted via Bluetooth communication to the smartphone device. A fake incoming call warning service alerts the driver if his or her safety level is suspiciously compromised. Realistic testing of the system demonstrates the practical benefits of multiple features and their fusion in providing a more authentic and effective driver safety monitoring. PMID:23247416

Chickenpox Can Be Serious. Protect Yourself and Your Child.

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US Adults Drink 17 Billion Binge Drinks a Year

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Tuberculosis: Learn the Signs and Symptoms of TB Disease

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Necrotizing Fasciitis: A Rare Disease, Especially for the Healthy

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E-Cigarettes and Young People: A Public Health Concern

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DOE Office of Scientific and Technical Information (OSTI.GOV)

Ramuhalli, Pradeep; Hirt, Evelyn H.; Veeramany, Arun

This research report summaries the development and evaluation of a prototypic enhanced risk monitor (ERM) methodology (framework) that includes alternative risk metrics and uncertainty analysis. This updated ERM methodology accounts for uncertainty in the equipment condition assessment (ECA), the prognostic result, and the probabilistic risk assessment (PRA) model. It is anticipated that the ability to characterize uncertainty in the estimated risk and update the risk estimates in real time based on equipment condition assessment (ECA) will provide a mechanism for optimizing plant performance while staying within specified safety margins. These results (based on impacting active component O&M using real-time equipmentmore » condition information) are a step towards ERMs that, if integrated with AR supervisory plant control systems, can help control O&M costs and improve affordability of advanced reactors.« less

Impact of the 2011 FDA transvaginal mesh safety update on AUGS members' use of synthetic mesh and biologic grafts in pelvic reconstructive surgery.

PubMed

Clemons, Jeffrey L; Weinstein, Milena; Guess, Marsha K; Alperin, Marianna; Moalli, Pamela; Gregory, William Thomas; Lukacz, Emily S; Sung, Vivian W; Chen, Bertha H; Bradley, Catherine S

2013-01-01

To describe the frequency of use and recent change in use of synthetic mesh and biologic grafts in pelvic organ prolapse (POP) and stress urinary incontinence surgery by American Urogynecology Society (AUGS) members. An electronic survey of AUGS members was conducted between December 2011 and January 2012. Frequency of graft use in POP (overall and by transvaginal and transabdominal approaches) and stress urinary incontinence surgery was queried relative to the timing of the 2011 Food and Drug Administration (FDA) safety update. Rates of materials' use before and after the statement were compared using Wilcoxon signed rank test. Fifty-three percent (507/962) of AUGS members responded and were included in analysis; 79% were urogynecologists. Before the FDA warning, in POP surgery, most (90%) used synthetic mesh and fewer (34%) used biologic grafts; 99% used synthetic mesh slings. After the FDA statement, respondents reported an overall decrease in the percent of POP cases in which they used synthetic mesh (P < 0.001) but no change in biologic graft use for POP (P = 0.37) or synthetic mesh sling use (P = 0.10). Specifically, transvaginal mesh use decreased: 40% reported decreased use and 12% stopped use. However, transvaginal mesh was still used by 61% of respondents in at least some cases. No change (62%) or increased use (12%) of mesh was reported for transabdominal POP procedures. Synthetic mesh use in transvaginal POP surgery decreased after the 2011 FDA safety update, but synthetic mesh use for transabdominal POP repair and sling procedures and overall biologic graft use in POP surgery did not decrease.

SNAPSHOT: A MODERN, SUSTAINABLE HOLDUP MEASUREMENT SYSTEM

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rowe, Nathan C; Younkin, James R; Smith, Steven E

2016-01-01

SNAPSHOT is a software platform designed to eventually replace Holdup Measurement System 4 (HMS 4), which is the current state-of-the-art for acquisition and analysis of nondestructive assay measurement data for in situ nuclear materials, holdup, in support of criticality safety and material control and accounting. HMS 4 is over 10 years old and is currently unsustainable due to hardware and software incompatibilities that have arisen from advances in detector electronics, primarily updates to multi-channel analyzers (MCAs), and both computer and handheld operating systems. SNAPSHOT is a complete redesign of HMS 4 that addresses the issue of compatibility with modern MCAsmore » and operating systems and that is designed with a flexible architecture to support long-term sustainability. It also provides an updated and more user friendly interface and is being developed under an NQA 1 software quality assurance (SQA) program to facilitate site acceptance for safety-related applications. This paper provides an overview of the SNAPSHOT project including details of the software development process, the SQA program, and the architecture designed to support sustainability.« less

49 CFR 390.203 - PRISM State registration/biennial updates.

Code of Federal Regulations, 2013 CFR

2013-10-01

... the Performance and Registration Information Systems Management (PRISM) program (authorized under... FEDERAL MOTOR CARRIER SAFETY REGULATIONS; GENERAL Unified Registration System § 390.203 PRISM State... procedures, provided the State has integrated the USDOT registration/update capability into its vehicle...

49 CFR 390.203 - PRISM State registration/biennial updates.

Code of Federal Regulations, 2014 CFR

2014-10-01

... the Performance and Registration Information Systems Management (PRISM) program (authorized under... FEDERAL MOTOR CARRIER SAFETY REGULATIONS; GENERAL Unified Registration System § 390.203 PRISM State... procedures, provided the State has integrated the USDOT registration/update capability into its vehicle...

Indicators of School Crime and Safety: 2012. NCES 2013-036/NCJ 241446

ERIC Educational Resources Information Center

Robers, Simone; Kemp, Jana; Truman, Jennifer

2013-01-01

Establishing reliable indicators of the current state of school crime and safety across the nation and regularly updating and monitoring these indicators is important in ensuring the safety of our nation's students. This is the aim of "Indicators of School Crime and Safety." This report is the fifteenth in a series of annual publications…

Efficacy, Tolerability, and Safety of Blonanserin in Schizophrenia: An Updated and Extended Systematic Review and Meta-Analysis of Randomized Controlled Trials.

PubMed

Kishi, Taro; Matsui, Yuki; Matsuda, Yuki; Katsuki, Asuka; Hori, Hikaru; Yanagimoto, Hiroko; Sanada, Kenji; Morita, Kiichiro; Yoshimura, Reiji; Shoji, Yoshihisa; Hagi, Katsuhiko; Iwata, Nakao

2018-03-07

We conducted an updated systematic review and meta-analysis of randomized controlled trials (RCTs) comparing blonanserin with other antipsychotics (amisulpride, aripiprazole, haloperidol, paliperidone, and risperidone). Weighted mean difference (WMD), risk ratio, and number needed to harm (NNH) with 95% confidence intervals (95% CIs) were calculated using random-effects model. Ten RCTs (n = 1521) were included in this study. Blonanserin was superior to aripiprazole in improvement of Positive and Negative Syndrome Scale total scores (WMD = -10.62, 95% CI = -17.67 to -3.560, p = 0.003). Blonanserin was associated with a higher incidence of all-cause discontinuation (RR = 1.373, 95% CI = 1.088-1.734, p = 0.008, NNH = 11), akathisia, extrapyramidal disorder, and agitation/excitement and a lower risk of hyperprolactinemia compared with risperidone + paliperidone. The current meta-analytic study did not update the comparison of blonanserin vs. haloperidol because there were no new RCTs. Our results suggest that the efficacy of blonanserin for schizophrenia is comparable with that of other antipsychotics, and blonanserin seems to be well tolerated. © Georg Thieme Verlag KG Stuttgart · New York.

76 FR 72997 - Railroad Safety Advisory Committee (RSAC); Working Group Activity Update

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-28

... equivalent in safety to equipment meeting the design standards in the Passenger Equipment Safety Standards..., locomotive alerters, and remote control locomotives. The group reached consensus regarding critical... employee and their railroad contractor and subcontractor equivalents, as required by RSIA. The group has...

Update and enhancement of ODOT's crash reduction factors.

DOT National Transportation Integrated Search

2006-06-01

Appropriate selection of cost-effective countermeasures for highway safety improvement projects requires an : estimate of the safety effects of alternative designs. The Oregon Department of Transportation (ODOT), like many : agencies, makes these est...

77 FR 32433 - Proposed FOIA Fee Schedule Update

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-01

...Pursuant to 10 CFR 1703.107(b)(6) of the Board's regulations, the Defense Nuclear Facilities Safety Board is publishing its proposed Freedom of Information Act (FOIA) Fee Schedule Update and solicits comments from interested organizations and individual members of the public.

29 CFR 1904.33 - Retention and updating.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR RECORDING AND REPORTING OCCUPATIONAL INJURIES AND ILLNESSES Other OSHA Injury and Illness Recordkeeping Requirements § 1904.33 Retention and updating. (a) Basic requirement. You must save the OSHA 300 Log, the...

29 CFR 1904.33 - Retention and updating.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR RECORDING AND REPORTING OCCUPATIONAL INJURIES AND ILLNESSES Other OSHA Injury and Illness Recordkeeping Requirements § 1904.33 Retention and updating. (a) Basic requirement. You must save the OSHA 300 Log, the...

Assessment of NHTSA’s Report “Relationships Between Fatality Risk, Mass, and Footprint in Model Year 2000-2007 Passenger Cars and LTVs”

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wenzel, Tom

2012-08-01

NHTSA recently completed a logistic regression analysis updating its 2003 and 2010 studies of the relationship between vehicle mass and US fatality risk per vehicle mile traveled (VMT). The new study updates the previous analyses in several ways: updated FARS data from 2002 to 2008 for MY00 to MY07 vehicles are used; induced exposure data from police reported crashes in several additional states are added; a new vehicle category for car-based crossover utility vehicles (CUVs) and minivans is created; crashes with other light-duty vehicles are divided into two groups based on the crash partner vehicle’s weight, and a category formore » all other fatal crashes is added; and new control variables for new safety technologies and designs, such as electronic stability controls (ESC), side airbags, and methods to meet voluntary agreement to improve light truck compatibility with cars, are included.« less

Assessment of NHTSA’s Report “Relationships Between Fatality Risk, Mass, and Footprint in Model Year 2000-2007 Passenger Cars and LTVs”

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wenzel, Tom

2011-09-01

NHTSA recently completed a logistic regression analysis updating its 2003 and 2010 studies of the relationship between vehicle mass and US fatality risk per vehicle mile traveled (VMT). The new study updates the previous analyses in several ways: updated FARS data from 2002 to 2008 for MY00 to MY07 vehicles are used; induced exposure data from police reported crashes in several additional states are added; a new vehicle category for car-based crossover utility vehicles (CUVs) and minivans is created; crashes with other light-duty vehicles are divided into two groups based on the crash partner vehicle’s weight, and a category formore » all other fatal crashes is added; and new control variables for new safety technologies and designs, such as electronic stability controls (ESC), side airbags, and methods to meet voluntary agreement to improve light truck compatibility with cars, are included.« less

78 FR 49996 - Pipeline Safety: Periodic Updates of Regulatory References to Technical Standards and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-16

..., natural gas and other types of materials transported by pipeline, it is not possible to establish... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Parts..., Transportation of Natural and Other Gas by Pipeline: Minimum Federal Safety Standards; 49 CFR part 193, Liquefied...

An observational survey of safety belt and child safety seat use in Virginia : the 1988 update.

DOT National Transportation Integrated Search

1989-01-01

Observational surveys of safety belt use in Virginia have been conducted in two series. The first covered 1974 through 1977, and the second 1983 through 1988. This report is concerned only with the latter series and encompasses use rates that are the...

The in-depth safety assessment (ISA) pilot projects in Ukraine.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kot, C. A.

1998-02-10

Ukraine operates pressurized water reactors of the Soviet-designed type, VVER. All Ukrainian plants are currently operating with annually renewable permits until they update their safety analysis reports (SARs). After approval of the SARS by the Ukrainian Nuclear Regulatory Authority, the plants will be granted longer-term operating licenses. In September 1995, the Nuclear Regulatory Authority and the Government Nuclear Power Coordinating Committee of Ukraine issued a new contents requirement for the safety analysis reports of VVERs in Ukraine. It contains requirements in three major areas: design basis accident (DBA) analysis, probabilistic risk assessment (PRA), and beyond design-basis accident (BDBA) analysis. Themore » DBA requirements are an expanded version of the older SAR requirements. The last two requirements, on PRA and BDBA, are new. The US Department of Energy (USDOE), through the International Nuclear Safety Program (INSP), has initiated an assistance and technology transfer program to Ukraine to assist their nuclear power stations in developing a Western-type technical basis for the new SARS. USDOE sponsored In-Depth Safety Assessments (ISAs) have been initiated at three pilot nuclear reactor units in Ukraine, South Ukraine Unit 1, Zaporizhzhya Unit 5, and Rivne Unit 1. USDOE/INSP have structured the ISA program in such a way as to provide maximum assistance and technology transfer to Ukraine while encouraging and supporting the Ukrainian plants to take the responsibility and initiative and to perform the required assessments.« less

Effects of efforts to optimise morbidity and mortality rounds to serve contemporary quality improvement and educational goals: a systematic review.

PubMed

Smaggus, Andrew; Mrkobrada, Marko; Marson, Alanna; Appleton, Andrew

2018-01-01

The quality and safety movement has reinvigorated interest in optimising morbidity and mortality (M&M) rounds. We performed a systematic review to identify effective means of updating M&M rounds to (1) identify and address quality and safety issues, and (2) address contemporary educational goals. Relevant databases (Medline, Embase, PubMed, Education Resource Information Centre, Cumulative Index to Nursing and Allied Health Literature, Healthstar, and Global Health) were searched to identify primary sources. Studies were included if they (1) investigated an intervention applied to M&M rounds, (2) reported outcomes relevant to the identification of quality and safety issues, or educational outcomes relevant to quality improvement (QI), patient safety or general medical education and (3) included a control group. Study quality was assessed using the Medical Education Research Study Quality Instrument and Newcastle-Ottawa Scale-Education instruments. Given the heterogeneity of interventions and outcome measures, results were analysed thematically. The final analysis included 19 studies. We identified multiple effective strategies (updating objectives, standardising elements of rounds and attaching rounds to a formal quality committee) to optimise M&M rounds for a QI/safety purpose. These efforts were associated with successful integration of quality and safety content into rounds, and increased implementation of QI interventions. Consistent effects on educational outcomes were difficult to identify, likely due to the use of methodologies ill-fitted for educational research. These results are encouraging for those seeking to optimise the quality and safety mission of M&M rounds. However, the inability to identify consistent educational effects suggests the investigation of M&M rounds could benefit from additional methodologies (qualitative, mixed methods) in order to understand the complex mechanisms driving learning at M&M rounds. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

The role of PRA in the safety assessment of VVER Nuclear Power Plants in Ukraine.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kot, C.

1999-05-10

Ukraine operates thirteen (13) Soviet-designed pressurized water reactors, VVERS. All Ukrainian plants are currently operating with annually renewable permits until they update their safety analysis reports (SARs), in accordance with new SAR content requirements issued in September 1995, by the Nuclear Regulatory Authority and the Government Nuclear Power Coordinating Committee of Ukraine. The requirements are in three major areas: design basis accident (DBA) analysis, probabilistic risk assessment (PRA), and beyond design-basis accident (BDBA) analysis. The last two requirements, on PRA and BDBA, are new, and the DBA requirements are an expanded version of the older SAR requirements. The US Departmentmore » of Energy (USDOE), as part of its Soviet-Designed Reactor Safety activities, is providing assistance and technology transfer to Ukraine to support their nuclear power plants (NPPs) in developing a Western-type technical basis for the new SARs. USDOE sponsored In-Depth Safety Assessments (ISAs) are in progress at three pilot nuclear reactor units in Ukraine, South Ukraine Unit 1, Zaporizhzhya Unit 5, and Rivne Unit 1, and a follow-on study has been initiated at Khmenytskyy Unit 1. The ISA projects encompass most areas of plant safety evaluation, but the initial emphasis is on performing a detailed, plant-specific Level 1 Internal Events PRA. This allows the early definition of the plant risk profile, the identification of risk significant accident sequences and plant vulnerabilities and provides guidance for the remainder of the safety assessments.« less

Preparing for the update of New Hampshire’s strategic highway safety plan.

DOT National Transportation Integrated Search

2015-01-01

NHDOTs objectives in requesting the peer exchange were to: Build a sustainable SHSP by energizing existing and developing cooperative partnerships among highway safety stakeholders; Strengthen the goals, strategies, and performance trackin...

Halloween Safety: Costumes, Candy, and Colored Contact Lenses

MedlinePlus

... Consumer Updates Halloween Safety: Costumes, Candy, and Colored Contact Lenses Share Tweet Linkedin Pin it More sharing ... or witch, poor costume choices—including decorative (colored) contact lenses and flammable costumes—and face paint allergies ...

2011 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

Dumont, Alan G.

2012-01-01

Welcome to the 2011 edition of the NASA Range Safety Annual Report. Funded by NASA Headquarters, this report provides a NASA Range Safety overview for current and potential range users. As is typical with odd year editions, this is an abbreviated Range Safety Annual Report providing updates and links to full articles from the previous year's report. It also provides more complete articles covering new subject areas, summaries of various NASA Range Safety Program activities conducted during the past year, and information on several projects that may have a profound impact on the way business will be done in the future. Specific topics discussed and updated in the 2011 NASA Range Safety Annual Report include a program overview and 2011 highlights; Range Safety Training; Range Safety Policy revision; Independent Assessments; Support to Program Operations at all ranges conducting NASA launch/flight operations; a continuing overview of emerging range safety-related technologies; and status reports from all of the NASA Centers that have Range Safety responsibilities. Every effort has been made to include the most current information available. We recommend this report be used only for guidance and that the validity and accuracy of all articles be verified for updates. Once again the web-based format was used to present the annual report. We continually receive positive feedback on the web-based edition and hope you enjoy this year's product as well. As is the case each year, contributors to this report are too numerous to mention, but we thank individuals from the NASA Centers, the Department of Defense, and civilian organizations for their contributions. In conclusion, it has been a busy and productive year. I'd like to extend a personal Thank You to everyone who contributed to make this year a successful one, and I look forward to working with all of you in the upcoming year.

Updated Interim Efficacy Analysis and Long-term Safety of Abiraterone Acetate in Metastatic Castration-resistant Prostate Cancer Patients Without Prior Chemotherapy (COU-AA-302)

PubMed Central

Rathkopf, Dana E.; Smith, Matthew R.; de Bono, Johann S.; Logothetis, Christopher J.; Shore, Neal D.; de Souza, Paul; Fizazi, Karim; Mulders, Peter F.A.; Mainwaring, Paul; Hainsworth, John D.; Beer, Tomasz M.; North, Scott; Fradet, Yves; Van Poppel, Hendrik; Carles, Joan; Flaig, Thomas W.; Efstathiou, Eleni; Yu, Evan Y.; Higano, Celestia S.; Taplin, Mary-Ellen; Griffin, Thomas W.; Todd, Mary; Yu, Margaret; Park, Youn C.; Kheoh, Thian; Small, Eric J.; Scher, Howard I.; Molina, Arturo; Ryan, Charles J.; Saad, Fred

2015-01-01

Background Abiraterone acetate (an androgen biosynthesis inhibitor) plus prednisone is approved for treating patients with metastatic castration-resistant prostate cancer (mCRPC). Study COU-AA-302 evaluated abiraterone acetate plus prednisone versus prednisone alone in mildly symptomatic or asymptomatic patients with progressive mCRPC without prior chemotherapy. Objective Report the prespecified third interim analysis (IA) of efficacy and safety outcomes in study COU-AA-302. Design, setting, and participants Study COU-AA-302, a double-blind placebo-controlled study, enrolled patients with mCRPC from April 2009 to June 2010. A total of 1088 patients were stratified by Eastern Cooperative Oncology Group performance status (0 vs 1). Intervention Patients were randomised 1:1 to abiraterone 1000 mg plus prednisone 5 mg twice daily by mouth versus prednisone. Outcome measurements and statistical analysis Co–primary end points were radiographic progression-free survival (rPFS) and overall survival (OS). Median times to event outcomes were estimated using the Kaplan-Meier method. Hazard ratios (HRs) and 95% confidence intervals (CIs) were derived using the Cox model, and treatment comparison used the log-rank test. The O’Brien-Fleming Lan-DeMets α-spending function was used for OS. Adverse events were summarised descriptively. Results and limitations With a median follow-up duration of 27.1 mo, improvement in rPFS was statistically significant with abiraterone treatment versus prednisone (median: 16.5 vs 8.2 mo; HR: 0.52 [95% CI, 0.45–0.61]; p < 0.0001). Abiraterone improved OS (median: 35.3 vs 30.1 mo; HR: 0.79 [95% CI, 0.66–0.95]; p = 0.0151) but did not reach the prespecified statistical efficacy boundary (α-level: 0.0035). A post hoc multivariate analysis for OS using known prognostic factors supported the primary results (HR: 0.74 [95% CI, 0.61–0.89]; p = 0.0017), and all clinically relevant secondary end points and patient-reported outcomes improved. While the post hoc nature of the long-term safety analysis is a limitation, the safety profile with longer treatment exposure was consistent with prior reports. Conclusions The updated IA of study COU-AA-302 in patients with mCRPC without prior chemotherapy confirms that abiraterone delays disease progression, pain, and functional deterioration and has clinical benefit with a favourable safety profile, including in patients treated for ≥24 mo. Trial registration Study COU-AA-302, ClinicalTrials.gov number, NCT00887198. PMID:24647231

2016 Updated American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards, Including Standards for Pediatric Oncology.

PubMed

Neuss, Michael N; Gilmore, Terry R; Belderson, Kristin M; Billett, Amy L; Conti-Kalchik, Tara; Harvey, Brittany E; Hendricks, Carolyn; LeFebvre, Kristine B; Mangu, Pamela B; McNiff, Kristen; Olsen, MiKaela; Schulmeister, Lisa; Von Gehr, Ann; Polovich, Martha

2016-12-01

Purpose To update the ASCO/Oncology Nursing Society (ONS) Chemotherapy Administration Safety Standards and to highlight standards for pediatric oncology. Methods The ASCO/ONS Chemotherapy Administration Safety Standards were first published in 2009 and updated in 2011 to include inpatient settings. A subsequent 2013 revision expanded the standards to include the safe administration and management of oral chemotherapy. A joint ASCO/ONS workshop with stakeholder participation, including that of the Association of Pediatric Hematology Oncology Nurses and American Society of Pediatric Hematology/Oncology, was held on May 12, 2015, to review the 2013 standards. An extensive literature search was subsequently conducted, and public comments on the revised draft standards were solicited. Results The updated 2016 standards presented here include clarification and expansion of existing standards to include pediatric oncology and to introduce new standards: most notably, two-person verification of chemotherapy preparation processes, administration of vinca alkaloids via minibags in facilities in which intrathecal medications are administered, and labeling of medications dispensed from the health care setting to be taken by the patient at home. The standards were reordered and renumbered to align with the sequential processes of chemotherapy prescription, preparation, and administration. Several standards were separated into their respective components for clarity and to facilitate measurement of adherence to a standard. Conclusion As oncology practice has changed, so have chemotherapy administration safety standards. Advances in technology, cancer treatment, and education and training have prompted the need for periodic review and revision of the standards. Additional information is available at http://www.asco.org/chemo-standards .

78 FR 51664 - Vessel Traffic Service Updates, Including Establishment of Vessel Traffic Service Requirements...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-21

... requirements. The changes made by this rule will align regulations with the current operating procedures of the... History V. Discussion of Comments and Changes VI. Regulatory Analyses A. Regulatory Planning and Review B... Waterways Safety System PWSA Ports and Waterways Safety Act SOLAS International Convention for the Safety of...

Efforts to update firefighter safety zone guidelines

Treesearch

Bret Butler

2009-01-01

One of the most critical decisions made on wildland fires is the identification of suitable safety zones for firefighters during daily fire management operations. To be effective (timely, repeatable, and accurate), these decisions rely on good training and judgment, but also on clear, concise guidelines. This article is a summary of safety zone guidelines and the...

Fatality reduction by safety belts for front-seat occupants of cars and light trucks : updated and expanded estimates based on 1986-99 FARS data

DOT National Transportation Integrated Search

2000-12-01

The National Highway Traffic Safety Administration estimated in 1984 that manual 3-point safety belts : reduce the fatality risk of front-seat occupants of passenger cars by 45 percent relative to the unrestrained : occupant. The agency still relies ...

Indicators of School Crime and Safety: 2001.

ERIC Educational Resources Information Center

Kaufman, Phillip; Chen, Xianglei; Choy, Susan P.; Peter, Katharin; Ruddy, Sally A.; Miller, Amanda K.; Fleury, Jill K.; Chandler, Kathryn A.; Planty, Michael G.; Rand, Michael R.

2001-01-01

Presents the latest indicator data on school crime and student safety, including updates on student and teacher victimization, weapons and fights at school, students' alcohol and marijuana use, and students' reports of drug availability at school. Data present a mixed picture of school safety, with a decline in overall crime rates but continued…

Ultrasound-Guided Regional Anesthesia and Patient Safety: Update of an Evidence-Based Analysis.

PubMed

Neal, Joseph M

2016-01-01

In 2010, the American Society of Regional Anesthesia and Pain Medicine's evidence-based medicine assessment of ultrasound (US)-guided regional anesthesia (UGRA) analyzed the effect of this nerve localization technology on patient safety. That analysis focused on 4 important regional anesthesia complications: peripheral nerve injury, local anesthetic systemic toxicity (LAST), hemidiaphragmatic paresis (HDP), and pneumothorax. In the intervening 5 years, further research has allowed us to refine our original conclusions. This update reviews previous findings and critically evaluates new literature published since late 2009 that compares the patient safety attributes of UGRA with those of traditional nerve localization methods. As with the previous version of this exercise, analysis focused on randomized controlled trials that compared UGRA with an alternative neural localization method and case series of more than 500 patients. The Jadad score was used to grade individual study quality, and conclusions were graded as to strength of evidence. Of those randomized controlled trials identified by our search techniques, 28 compared the incidence of postoperative nerve symptoms, 27 assessed LAST parameters, 7 studied HDP, and 9 reported the incidence of pneumothorax. The current analysis strengthens our original conclusions that US guidance has no significant effect on the incidence of postoperative neurologic symptoms and that UGRA reduces the incidence and intensity of HDP but does so in an unpredictable manner. Conversely, emerging evidence supports the effectiveness of US guidance for reducing LAST across its clinical presentation continuum. The predicted frequency of pneumothorax has grown smaller in tandem with increased experience with US-guided supraclavicular block. This evidence-based review summarizes both the power and the limitations of UGRA as a tool for improving patient safety. Since the original 2010 publication of this analysis, evidence has continued to support the concept that ultrasound (US) guidance does not meaningfully affect the incidence of peripheral nerve injury (PNI) associated with regional anesthesia. Similar confirmatory evidence attests to US guidance reducing the incidence and intensity of hemidiaphragmatic paresis (HDP) but not eliminating it. Literature published since late 2009 reports the effective role of US guidance in reducing the incidence of local anesthetic systemic toxicity and allows calculation of a lower predicted frequency of pneumothorax associated with US-guided supraclavicular blocks.

Post hoc analysis of Japanese patients from the placebo-controlled PREVAIL trial of enzalutamide in patients with chemotherapy-naive, metastatic castration-resistant prostate cancer-updated results.

PubMed

Kimura, Go; Ueda, Takeshi

2017-03-01

A post hoc analysis of interim results from PREVAIL, a Phase III, double-blind, placebo-controlled trial of men with metastatic castration-resistant prostate cancer, demonstrated that the treatment effects, safety and pharmacokinetics of enzalutamide in Japanese patients were generally consistent with those of the overall population. A recent longer term analysis of PREVAIL demonstrated continued benefit of enzalutamide treatment over placebo. Here, we report results from a post hoc analysis of Japanese patients enrolled in PREVAIL at the prespecified number of deaths for the final analysis. In Japanese patients, enzalutamide reduced the risk of death by 35% (hazard ratio, 0.65; 95% confidence interval, 0.28-1.51) and the risk of investigator-assessed radiographic progression or death by 60% (hazard ratio, 0.40; 95% confidence interval, 0.18-0.90). These results show that treatment effects and safety in Japanese patients in the final analysis of PREVAIL continued to be generally consistent with those of the overall population. © The Author 2016. Published by Oxford University Press.

Post hoc analysis of Japanese patients from the placebo-controlled PREVAIL trial of enzalutamide in patients with chemotherapy-naive, metastatic castration-resistant prostate cancer—updated results

PubMed Central

Ueda, Takeshi

2017-01-01

Abstract A post hoc analysis of interim results from PREVAIL, a Phase III, double-blind, placebo-controlled trial of men with metastatic castration-resistant prostate cancer, demonstrated that the treatment effects, safety and pharmacokinetics of enzalutamide in Japanese patients were generally consistent with those of the overall population. A recent longer term analysis of PREVAIL demonstrated continued benefit of enzalutamide treatment over placebo. Here, we report results from a post hoc analysis of Japanese patients enrolled in PREVAIL at the prespecified number of deaths for the final analysis. In Japanese patients, enzalutamide reduced the risk of death by 35% (hazard ratio, 0.65; 95% confidence interval, 0.28–1.51) and the risk of investigator-assessed radiographic progression or death by 60% (hazard ratio, 0.40; 95% confidence interval, 0.18–0.90). These results show that treatment effects and safety in Japanese patients in the final analysis of PREVAIL continued to be generally consistent with those of the overall population. PMID:28003320

Infanrix hexa and sudden death: a review of the periodic safety update reports submitted to the European Medicines Agency.

PubMed

Puliyel, Jacob; Sathyamala, C

2018-01-01

There have been a number of spontaneous reports of sudden unexpected death soon after the administration of Infanrix hexa (combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenza type B vaccine). The manufacturer, GlaxoSmithKline (GSK), submits confidential periodic safety update reports (PSURs) on Infanrix hexa to the European Medicines Agency (EMA). The latest is the PSUR 19. Each PSUR contains an analysis of observed/expected sudden deaths, which shows that the number of observed deaths soon after immunisation is lower than that expected by chance. This commentary focuses on that aspect of the PSUR which has a bearing on policy decisions. We analysed the data provided in the PSURs. It is apparent that the deaths acknowledged in the PSUR 16 were deleted from the PSUR 19. The number of observed deaths soon after vaccination among children older than one year was significantly higher than that expected by chance once the deleted deaths were restored and included in the analysis. The manufacturer must explain the figures that have been submitted to the regulatory authorities. The procedures undertaken by the EMA to evaluate the manufacturer's claims in the PSUR need to be reviewed. The Drugs Controller General of India nearly automatically accepts drugs and vaccines approved by the EMA. There is a need to reappraise the reliance on due diligence by the EMA.

E2C(R2) Periodic Benefit-Risk Evaluation Report and E2C(R2) Periodic Benefit-Risk Evaluation Report--Questions and Answers; International Council for Harmonisation; Guidances for Industry; Availability. Notice.

PubMed

2016-07-19

The Food and Drug Administration (FDA or Agency) is announcing the availability of guidances for industry entitled ``E2C(R2) Periodic Benefit-Risk Evaluation'' (E2C(R2) guidance) and ``E2C(R2) Periodic Benefit-Risk Evaluation Report--Questions and Answers'' (E2C(R2) Q&A guidance). These guidances were prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The E2C(R2) draft guidance, issued April 11, 2012, updated and combined two ICH guidances, ``E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (addendum to the E2C guidance). The E2C(R2) guidance is intended to describe the format, content, and timing of a Periodic Benefit-Risk Evaluation Report (PBRER) for an approved drug or biologic, and it finalizes the draft guidance. The E2C(R2) Q&A guidance is a supplementary guidance that is intended to clarify key issues in the E2C(R2) guidance.

Nonvitamin-K-antagonist oral anticoagulants versus warfarin in patients with atrial fibrillation and previous stroke or transient ischemic attack: An updated systematic review and meta-analysis of randomized controlled trials.

PubMed

Ntaios, George; Papavasileiou, Vasileios; Diener, Hans-Chris; Makaritsis, Konstantinos; Michel, Patrik

2017-08-01

Background In a previous systematic review and meta-analysis, we assessed the efficacy and safety of nonvitamin-K antagonist oral anticoagulants versus warfarin in patients with atrial fibrillation and stroke or transient ischemic attack. Since then, new information became available. Aim The aim of the present work was to update the results of the previous systematic review and meta-analysis. Methods We searched PubMed until 24 August 2016 for randomized controlled trials using the following search items: "atrial fibrillation" and "anticoagulation" and "warfarin" and "previous stroke or transient ischemic attack." Eligible studies had to be phase III trials in patients with atrial fibrillation comparing warfarin with nonvitamin-K antagonist oral anticoagulants currently on the market or with the intention to be brought to the market in North America or Europe. The outcomes assessed in the efficacy analysis included stroke or systemic embolism, stroke, ischemic or unknown stroke, disabling or fatal stroke, hemorrhagic stroke, cardiovascular death, death from any cause, and myocardial infarction. The outcomes assessed in the safety analysis included major bleeding, intracranial bleeding, and major gastrointestinal bleeding. We performed fixed effects analyses on intention-to-treat basis. Results Among 183 potentially eligible articles, four were included in the meta-analysis. In 20,500 patients, compared to warfarin, nonvitamin-K antagonist oral anticoagulants were associated with a significant reduction of stroke/systemic embolism (relative risk reduction: 13.7%, absolute risk reduction: 0.78%, number needed to treat to prevent one event: 127), hemorrhagic stroke (relative risk reduction: 50.0%, absolute risk reduction: 0.63%, number needed to treat: 157), any stroke (relative risk reduction: 13.1%, absolute risk reduction: 0.7%, number needed to treat: 142), and intracranial hemorrhage (relative risk reduction: 46.1%, absolute risk reduction: 0.88%, number needed to treat: 113) over 1.8-2.8 years. Conclusions This updated meta-analysis in 20,500 atrial fibrillation patients with previous stroke or transient ischemic attack shows that compared to warfarin non-vitamin-K antagonist oral anticoagulants are associated with a significant reduction of stroke, stroke or systemic embolism, hemorrhagic stroke, and intracranial bleeding.

78 FR 4150 - Update of NIOSH Nanotechnology Strategic Plan for Research and Guidance

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-18

...; NIOSH-134-B] Update of NIOSH Nanotechnology Strategic Plan for Research and Guidance AGENCY: National... Nanotechnology Strategic Plan for Research and Guidance. SUMMARY: The National Institute for Occupational Safety... NIOSH FY2013-FY2016 nanotechnology strategic plan. This draft strategic plan (Protecting the...

10 CFR 63.44 - Changes, tests, and experiments.

Code of Federal Regulations, 2011 CFR

2011-01-01

... waste isolation that are described in the SAR (as updated); and (ii) The design and performance... isolation, are operated or controlled. (6) Tests or experiments not described in the SAR (as updated) means... components important to safety, or important to waste isolation, are utilized, controlled, or altered in a...

10 CFR 63.44 - Changes, tests, and experiments.

Code of Federal Regulations, 2010 CFR

2010-01-01

... waste isolation that are described in the SAR (as updated); and (ii) The design and performance... isolation, are operated or controlled. (6) Tests or experiments not described in the SAR (as updated) means... components important to safety, or important to waste isolation, are utilized, controlled, or altered in a...

29 CFR 1904.44 - Retention and updating of old forms.

Code of Federal Regulations, 2010 CFR

2010-07-01

....44 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR RECORDING AND REPORTING OCCUPATIONAL INJURIES AND ILLNESSES Transition From the Former Rule § 1904.44 Retention and updating of old forms. You must save your copies of the OSHA 200 and 101...

29 CFR 1904.44 - Retention and updating of old forms.

Code of Federal Regulations, 2011 CFR

2011-07-01

....44 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR RECORDING AND REPORTING OCCUPATIONAL INJURIES AND ILLNESSES Transition From the Former Rule § 1904.44 Retention and updating of old forms. You must save your copies of the OSHA 200 and 101...

29 CFR 1904.44 - Retention and updating of old forms.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 29 Labor 5 2012-07-01 2012-07-01 false Retention and updating of old forms. 1904.44 Section 1904.44 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR RECORDING AND REPORTING OCCUPATIONAL INJURIES AND ILLNESSES Transition From the Former...

29 CFR 1904.44 - Retention and updating of old forms.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 29 Labor 5 2014-07-01 2014-07-01 false Retention and updating of old forms. 1904.44 Section 1904.44 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR RECORDING AND REPORTING OCCUPATIONAL INJURIES AND ILLNESSES Transition From the Former...

78 FR 65932 - Updating OSHA Standards Based on National Consensus Standards; Signage

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-04

...; Signage AGENCY: Occupational Safety and Health Administration (OSHA), Department of Labor. ACTION... accompanied its direct final rule revising its signage standards for general industry and construction. DATES... proposed rule (NPRM) along with the direct final rule (DFR) (see 78 FR 35585) updating its signage...

77 FR 68717 - Updating OSHA Standards Based on National Consensus Standards; Head Protection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-16

..., 1918, and 1926 [Docket No. OSH-2011-0184] RIN 1218-AC65 Updating OSHA Standards Based on National Consensus Standards; Head Protection AGENCY: Occupational Safety and Health Administration (OSHA), Labor. ACTION: Proposed rule; withdrawal. SUMMARY: With this notice, OSHA is withdrawing the proposed rule that...

77 FR 68684 - Updating OSHA Standards Based on National Consensus Standards; Head Protection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-16

..., 1918, and 1926 [Docket No. OSHA-2011-0184] RIN 1218-AC65 Updating OSHA Standards Based on National Consensus Standards; Head Protection AGENCY: Occupational Safety and Health Administration (OSHA), Labor. ACTION: Final rule; confirmation of effective date. SUMMARY: OSHA is confirming the effective date of its...

FDA Proposes New Safety Measures for Indoor Tanning Devices: The Facts

MedlinePlus

... Consumers Home For Consumers Consumer Updates FDA Proposes New Safety Measures for Indoor Tanning Devices: The Facts ... Website Policies U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888- ...

78 FR 48696 - Draft Revisions to the Marine Safety Manual, Volume III, Chapters 20-26

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-09

...) Updated provisions for vessel manning, including guidance for the issuing of safe manning documents; (2... Distress and Safety System (GMDSS), and the Principles of Minimum Safe Manning (IMO Resolution A.1047(27...

Capital Beltway update : Beltway user focus groups

DOT National Transportation Integrated Search

1998-04-01

Author's abstract: The Capital Beltway is 64 miles of roadway surrounding Washington, D.C. The Capital Beltway Safety Team, led by officials from Maryland and Virginia, was formed to address safety issues on this urban interstate highway. This report...

Safety Awareness & Communications Internship

NASA Technical Reports Server (NTRS)

Jefferson, Zanani

2015-01-01

The projects that I have worked on during my internships were updating the JSC Safety & Health Action Team JSAT Employee Guidebook, conducting a JSC mishap case study, preparing for JSC Today Close Call success stories, and assisting with event planning and awareness.

[Guidelines in RA treatment: concepts on safety and recommendations using anti-TNF-alpha inhibitors. Grupo de Estudio de Nuevas Terapias de Enfermedades reumáticas (GENTE)].

PubMed

Díaz-Jouanen, Efraín; Abud-Mendoza, Carlos; Garza-Elizondo, Mario Alberto; Medrano-Ramírez, Gabriel; Burgos-Vargas, Rubén; Orozco-Alcalá, José Javier; Pacheco-Tena, César Francisco; Pineda, Carlos; Pozos-Espíndola, Juan Carlos; Ramos-Niembro, Francisco; Robles-San-Román, Manuel; Santana-Sahagún, Jesús Ernesto

2009-01-01

Recommendations for the use of Disease-Modifying Antirheumatic Drugs (DMARD) with both conventional and biological agents in Rheumatoid Arthritis (RA) must be based on their safety profile, adverse effects, risks, and advantages. With the purpose of presenting the most updated information about the safety of tumor necrosis factor alpha (TNFalpha) antagonists, in this article we summarize the literature published during the last three years about this sort of biological agents in specific clinical situations, such as risk of developing infections, cancer, cardiovascular diseases, and autoimmunity; as well as their administration to patients who will undergo surgical procedures, pregnant and/or breast-feeding women, and patients who need immunizations. Likewise, in this analysis we offer specific recommendations, based on evidence, for the best anti-TNF-alfa management.

Safety Education Impact and Good Practice: A Review

ERIC Educational Resources Information Center

Mulvaney, Caroline A.; Watson, Michael C.; Errington, Gail

2012-01-01

Purpose: The aim of this literature review was to examine recent evidence of the impact of safety education for children and young people on unintentional injury rates and to update an earlier review. Evidence was sought that linked safety education for children and young people in schools, centres and other settings with changes in knowledge,…

Safety equipment list for the 241-SY-101 RAPID mitigation project

DOE Office of Scientific and Technical Information (OSTI.GOV)

MORRIS, K.L.

1999-06-29

This document provides the safety classification for the safety (safety class and safety RAPID Mitigation Project. This document is being issued as the project SEL until the supporting authorization basis documentation, this document will be superseded by the TWRS SEL (LMHC 1999), documentation istlralized. Upon implementation of the authorization basis significant) structures, systems, and components (SSCS) associated with the 241-SY-1O1 which will be updated to include the information contained herein.

Deployment of a tool for measuring freeway safety performance.

DOT National Transportation Integrated Search

2011-12-01

This project updated and deployed a freeway safety performance measurement tool, building upon a previous project that developed the core methodology. The tool evaluates the cumulative risk over time of an accident or a particular kind of accident. T...

Safety belt and motorcycle helmet use in Virginia : the 2000 update.

DOT National Transportation Integrated Search

2000-01-01

This series of surveys to determine the safety belt and motorcycle helmet use rates in Virginia was initiated to qualify the Commonwealth for incentive funds in accordance with the requirements of Section 153 of the Intermodal Surface Transportation ...

Safety belt and motorcycle helmet use in Virginia : the 1998 update.

DOT National Transportation Integrated Search

1998-11-01

This series of surveys to determine the safety belt and motorcycle helmet use rates in Virginia was initiated to qualify the Commonwealth for incentive funds in accordance with the requirements of Section 153 of the Intermodal Surface Transportation ...

Safety belt and motorcycle helmet use in Virginia : the 1996 update.

DOT National Transportation Integrated Search

1996-01-01

This series of surveys to determine the safety belt and motorcycle helmet use rates in Virginia was initiated to qualify the Commonwealth for incentive funds in accordance with the requirements of the Intermodal Surface Transportation Efficiency Act,...

Safety belt and motorcycle helmet use in Virginia : the 1999 update

DOT National Transportation Integrated Search

1999-09-01

This series of surveys to determine the safety belt and motorcycle helmet use rates in Virginia was initiated to qualify the Commonwealth for incentive funds in accordance with the requirements of Section 153 of the Intermodal Surface Transportation ...

Working paper : national costs of the metropolitan ITS infrastructure : updated with 2002 deployment data

DOT National Transportation Integrated Search

1995-02-01

This paper addresses the relationship of truck size and weight (TS&W) policy, vehicle handling and stability, and safety. Handling and stability are the primary mechanisms relating vehicle characteristics and safety. Vehicle characteristics may also ...

Safety belt and motorcycle helmet use in Virginia : the 1997 update.

DOT National Transportation Integrated Search

1997-10-01

This series of surveys to determine the safety belt and motorcycle helmet use rates in Virginia was initiated to qualify the Commonwealth for incentive funds in accordance with the requirements of Section 153 of the Intermodal Surface Transportation ...

Safety belt and motorcycle helmet use in Virginia : the December 2003 update.

DOT National Transportation Integrated Search

2004-01-01

The Virginia Transportation Research Council has been collecting safety belt use data in Virginia since 1974. Beginning in 1992, the data gathering methodology was changed to a statistically valid probability-based sampling plan in accordance with fe...

Intimidation: a concept analysis.

PubMed

Lamontagne, Clare

2010-01-01

Patient safety is being compromised by intimidating communication and ineffective teamwork among healthcare providers. The Joint Commission Update indicates that ineffective communication has been the leading root cause of the majority of sentinel events since 1996. Furthermore, the organizational implementation of policies and procedures for addressing this dangerous situation is now mandated by The Joint Commission Sentinel Event Alert. However, in order to consistently identify and address this problem, there must be a clear and universal definition of intimidation. The purpose of this article is to clarify the definition of intimidation in healthcare settings. Without this clarity, the role of intimidation as a precursor to the occurrence of medical errors will inevitably be obscured. The framework for concept analysis proposed by Walker and Avant is used to explicate the definition, attributes, antecedents, consequences, and cases of intimidation. Analyzing the extent of the relationship between intimidation and medical errors will provide healthcare organizations and professionals with a foundation for the development of strategies to combat the effects of intimidation on medical errors and patient safety. The necessity to create a culture of safety in healthcare settings is paramount.

Spent nuclear fuel project cold vacuum drying facility operations manual

DOE Office of Scientific and Technical Information (OSTI.GOV)

IRWIN, J.J.

This document provides the Operations Manual for the Cold Vacuum Drying Facility (CVDF). The Manual was developed in conjunction with HNF-SD-SNF-SAR-002, Safety Analysis Report for the Cold Vacuum Drying Facility, Phase 2, Supporting Installation of Processing Systems (Garvin 1998) and, the HNF-SD-SNF-DRD-002, 1997, Cold Vacuum Drying Facility Design Requirements, Rev. 3a. The Operations Manual contains general descriptions of all the process, safety and facility systems in the CVDF, a general CVD operations sequence, and has been developed for the SNFP Operations Organization and shall be updated, expanded, and revised in accordance with future design, construction and startup phases of themore » CVDF until the CVDF final ORR is approved.« less

76 FR 50669 - Safety Zones; Eleventh Coast Guard District Annual Fireworks Events

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-16

... occurring, add new unlisted annual fireworks events to the regulations, and standardize the format for all... to be added. In addition, information for those events that continue to occur has changed in some... sections will be updated or added as follows: update with current information existing events, add...

76 FR 16785 - Meeting for Software Developers on the Technical Specifications for Common Formats for Patient...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-25

... Software Developers on the Technical Specifications for Common Formats for Patient Safety Data Collection... designed as an interactive forum where PSOs and software developers can provide input on these technical... updated event descriptions, forms, and technical specifications for software developers. As an update to...

78 FR 35585 - Updating OSHA Standards Based on National Consensus Standards; Signage

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-13

...; Signage AGENCY: Occupational Safety and Health Administration (OSHA), Department of Labor. ACTION: Notice... Administration (``OSHA'' or ``the Agency'') proposes to update its general industry and construction signage... standards, ANSI Z53.1-1967, Z35.1-1968, and Z35.2-1968, in its signage standards, thereby providing...

Transit research and industry news update : November 2009.

DOT National Transportation Integrated Search

2009-11-01

SPECIAL...........................................................................................................................3 : Charter for Transit Rail Advisory Committee for Safety...........................................3 : U.S. Department...

Notification: FY 2012 Management Challenges and Internal Control Weaknesses for the Chemical Safety and Hazard Investigation Board

EPA Pesticide Factsheets

February 1, 2012. The EPA Office of Inspector General is beginning work to update our list of areas we consider to be the key management challenges confronting the Chemical Safety and Hazard Investigation Board.

Evidence report : chronic kidney disease and commercial motor vehicle driver safety

DOT National Transportation Integrated Search

2007-11-05

The purpose of this evidence report is to address several key questions posed by the Federal Motor Carrier Safety Administration (FMCSA). FMCSA developed each of these key questions so that the answers will provide information useful in updating its ...

Cell phone use while driving in North Carolina : 2002 update report

DOT National Transportation Integrated Search

2002-12-01

As a follow-on to an earlier study funded by the North Carolina Governor's Highway Safety Program, the current study was carried out to further understanding regarding the safety implications of cellular telephone use while driving. The study involve...

Notification: Key Management Challenges Confronting the U.S. Chemical Safety and Hazard Investigation Board

EPA Pesticide Factsheets

June 9, 2014. The OIG is beginning work to update the fiscal year 2014 list of areas we consider to be the key management challenges confronting the U.S. Chemical Safety and Hazard Investigation Board (CSB).

Endovascular Treatment of Ischemic Stroke: An Updated Meta-Analysis of Efficacy and Safety.

PubMed

Vidale, Simone; Agostoni, Elio

2017-05-01

Recent randomized trials demonstrated the superiority of the mechanical thrombectomy over the best medical treatment in patients with acute ischemic stroke due to an occlusion of arteries of proximal anterior circulation. In this updated meta-analysis, we aimed to summarize the total clinical effects of the treatment, including the last trials. We performed literature search of Randomized Crontrolled Trials (RCTs) published between 2010 and October 2016, comparing endovenous thrombolysis plus mechanical thrombectomy (intervention group) with best medical care alone (control group). We identified 8 trials. Primary outcomes were reduced disability at 90 days from the event and symptomatic intracranial hemorrhage. Statistical analysis was performed pooling data into the 2 groups, evaluating outcome heterogeneity. The Mantel-Haenszel method was used to calculate odds ratios (ORs). We analyzed data for 1845 patients (interventional group: 911; control group: 934). Mechanical thrombectomy contributed to a significant reduction in disability rate compared to the best medical treatment alone (OR: 2.087; 95% confidence interval [CI]: 1.718-2.535; P < .001). We calculated that for every 100 treated patients, 16 more participants have a good outcome as a result of mechanical treatment. No significant differences between groups were observed concerning the occurrence of symptomatic hemorrhage (OR: 1.021; 95% CI: 0.641-1.629; P = .739). Mechanical thrombectomy contributes to significantly increase the functional benefit of endovenous thrombolysis in patients with acute ischemic stroke caused by arterial occlusion of proximal anterior circulation, without reduction in safety. These findings are relevant for the optimization of the acute stroke management, including the implementation of networks between stroke centers.

Honoring the Past and Looking to the Future: Updates on Seminal Behavior Therapy Publications on Etiology and Mechanisms of Change.

PubMed

Newman, Michelle G

2016-09-01

This is the introduction to the first of two special issues in honor of the 50th anniversary of the Association for Behavioral and Cognitive Therapies. The goal of this issue is to pay tribute to prior seminal Behavior Therapy publications on etiology and mechanisms of change, to provide an updated review of important topics covered by these papers, and to make recommendations for the future. Each invited paper highlights a particular Behavior Therapy publication's contribution to our understanding and also provides an updated review or meta-analysis on the topic of the original paper. The topics covered here include mechanisms of etiology such as preparedness, reinforcement, and control. In terms of papers on mechanisms of change, we cover mechanisms related to extinction including fear activation, within- and between-session extinction, safety behaviors, and variables related to imagery. In addition, we examine principles related to generalization of learning and optimizing the impact of homework. With the two special issues of Behavior Therapy, we hope to inspire additional research and discussion. Copyright © 2016. Published by Elsevier Ltd.

Transit research and industry news update : December 2009.

DOT National Transportation Integrated Search

2010-12-01

SPECIAL............................................................................................................................3 : Transportation Secretary LaHood Proposes New Rail Safety Bill.............................3 : Federal Highway & Tra...

Bayesian networks for maritime traffic accident prevention: benefits and challenges.

PubMed

Hänninen, Maria

2014-12-01

Bayesian networks are quantitative modeling tools whose applications to the maritime traffic safety context are becoming more popular. This paper discusses the utilization of Bayesian networks in maritime safety modeling. Based on literature and the author's own experiences, the paper studies what Bayesian networks can offer to maritime accident prevention and safety modeling and discusses a few challenges in their application to this context. It is argued that the capability of representing rather complex, not necessarily causal but uncertain relationships makes Bayesian networks an attractive modeling tool for the maritime safety and accidents. Furthermore, as the maritime accident and safety data is still rather scarce and has some quality problems, the possibility to combine data with expert knowledge and the easy way of updating the model after acquiring more evidence further enhance their feasibility. However, eliciting the probabilities from the maritime experts might be challenging and the model validation can be tricky. It is concluded that with the utilization of several data sources, Bayesian updating, dynamic modeling, and hidden nodes for latent variables, Bayesian networks are rather well-suited tools for the maritime safety management and decision-making. Copyright © 2014 Elsevier Ltd. All rights reserved.

Safety belt and motorcycle helmet use in Virginia : the December 2002 update.

DOT National Transportation Integrated Search

2003-01-01

Safety belt use data were first collected in Virginia in 1974. Early data (1974-77 and 1983-86) were collected from only the four metropolitan areas (Northern Virginia, Tidewater, Richmond, and Roanoke) of the state. Between 1987 and 1992, data were ...

Safety belt and motorcycle helmet use in Virginia : the 2002 update.

DOT National Transportation Integrated Search

2002-01-01

Safety belt use data were first collected in Virginia in 1974. Early data (1974-77 and 1983-86) were collected from only the four metropolitan areas (Northern Virginia, Tidewater, Richmond, and Roanoke) of the state. Between 1987 and 1992, data were ...

Coast Guard : update on Marine Information for Safety and Law Enforcement System

DOT National Transportation Integrated Search

2001-10-01

The Coast Guard is developing a web-based information system to replace an aging computer system that it uses to track safety and law-enforcement actions involving commercial and recreational vessels. In 1995 the Coast Guard awarded a contract to dev...

The art of appropriate evaluation : a guide for highway safety program managers

DOT National Transportation Integrated Search

2008-08-01

The guide, updated from its original release in 1999, is intended for project managers who will oversee the evaluation of traffic safety programs. It describes the benefits of evaluation and provides an overview of the steps involved. The guide inclu...

The art of appropriate evaluation : a guide for highway safety program managers

DOT National Transportation Integrated Search

2008-12-01

The guide, updated from its original release in 1999, is intended for project managers who will oversee the evaluation of traffic safety programs. It describes the benefits of evaluation and provides an overview of the steps involved. The guide inclu...

Impact of edge lines on safety of rural two-lane highways.

DOT National Transportation Integrated Search

2005-10-01

This report documents the results of the project for Impact of Edge Lines on Safety of Rural Two Lane Highways. This research project was initiated in the effort of compliance with the updated version of the Manual on Uniform Traffic Control De...

Notification: Key Management Challenges Confronting the U.S. Chemical Safety and Hazard Investigation Board - FY2016

EPA Pesticide Factsheets

January 21, 2016. The EPA OIG is beginning work to update for fiscal year 2016 its list of proposed key management challenges and internal control weaknesses confronting the U.S. Chemical Safety and Hazard Investigation Board (CSB).

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sassani, David; Price, Laura L.; Rechard, Robert P.

This report provides an update to Sassani et al. (2016) and includes: (1) an updated set of inputs (Sections 2.3) on various additional waste forms (WF) covering both DOE-managed spent nuclear fuel (SNF) and DOE-managed (as) high-level waste (HLW) for use in the inventory represented in the geologic disposal safety analyses (GDSA); (2) summaries of evaluations initiated to refine specific characteristics of particular WF for future use (Section 2.4); (3) updated development status of the Online Waste Library (OWL) database (Section 3.1.2) and an updated user guide to OWL (Section 3.1.3); and (4) status updates (Section 3.2) for the OWLmore » inventory content, data entry checking process, and external OWL BETA testing initiated in fiscal year 2017.« less

Nine-Year Core Study Data for Sientra's FDA-Approved Round and Shaped Implants with High-Strength Cohesive Silicone Gel.

PubMed

Stevens, W Grant; Calobrace, M Bradley; Harrington, Jennifer; Alizadeh, Kaveh; Zeidler, Kamakshi R; d'Incelli, Rosalyn C

2016-04-01

Since approval in March 2012, data on Sientra's (Santa Barbara, CA) silicone gel implants have been updated and published regularly to provide immediate visibility to the continued safety and performance of these devices. The 9 year follow-up data support the previously published data confirming the ongoing safety and efficacy of Sientra silicone gel breast implants. The authors provide updated 9 year study data for Sientra's round and shaped silicone gel breast implants. The Core Study is an ongoing 10 year study that enrolled 1788 patients with 3506 Sientra implants across four indications (primary augmentation, revision-augmentation, primary reconstruction, and revision-reconstruction). For the safety analysis, Kaplan-Meier risk rates were calculated to evaluate postoperative complications, including all breast implant-related adverse effects. For the effectiveness analyses, results were presented through 8 years as patient satisfaction scores were assessed at even years. Through 9 years, the overall risk of capsular contracture was 12.6%. Smooth devices (16.6%, 95% CI, 14.2%, 19.5%) had a statistically significantly higher rate of capsular contracture compared to textured devices (8.0%, 95% CI, 6.2%, 10.4%). Out of the 610 reoperations in 477 patients, over half of all reoperations were due to cosmetic reasons (n = 315; 51.6%). Patient satisfaction remains high through 8 years, with 90% of primary augmentation patients indicating their breast implants look natural and feel soft. The 9-year follow-up data from the ongoing Core Study of the Sientra portfolio of HSC and HSC+ silicone gel breast implants reaffirm the very strong safety profile as well as continued patient satisfaction. 2 Therapeutic. © 2016 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

78 FR 66642 - Updating OSHA Standards Based on National Consensus Standards; Signage

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-06

... single standard is best. The ANSI Z535 designs, the traditional safety sign and tag designs, as well as... [Docket No. OSHA-2013-0005] RIN 1218-AC77 Updating OSHA Standards Based on National Consensus Standards... rule; confirmation of effective date. SUMMARY: On June 13, 2013, OSHA published in the Federal Register...

Criteria for the Research Institute for Fragrance Materials, Inc. (RIFM) safety evaluation process for fragrance ingredients.

PubMed

Api, A M; Belsito, D; Bruze, M; Cadby, P; Calow, P; Dagli, M L; Dekant, W; Ellis, G; Fryer, A D; Fukayama, M; Griem, P; Hickey, C; Kromidas, L; Lalko, J F; Liebler, D C; Miyachi, Y; Politano, V T; Renskers, K; Ritacco, G; Salvito, D; Schultz, T W; Sipes, I G; Smith, B; Vitale, D; Wilcox, D K

2015-08-01

The Research Institute for Fragrance Materials, Inc. (RIFM) has been engaged in the generation and evaluation of safety data for fragrance materials since its inception over 45 years ago. Over time, RIFM's approach to gathering data, estimating exposure and assessing safety has evolved as the tools for risk assessment evolved. This publication is designed to update the RIFM safety assessment process, which follows a series of decision trees, reflecting advances in approaches in risk assessment and new and classical toxicological methodologies employed by RIFM over the past ten years. These changes include incorporating 1) new scientific information including a framework for choosing structural analogs, 2) consideration of the Threshold of Toxicological Concern (TTC), 3) the Quantitative Risk Assessment (QRA) for dermal sensitization, 4) the respiratory route of exposure, 5) aggregate exposure assessment methodology, 6) the latest methodology and approaches to risk assessments, 7) the latest alternatives to animal testing methodology and 8) environmental risk assessment. The assessment begins with a thorough analysis of existing data followed by in silico analysis, identification of 'read across' analogs, generation of additional data through in vitro testing as well as consideration of the TTC approach. If necessary, risk management may be considered. Copyright © 2014 Elsevier Ltd. All rights reserved.

Constructing a Bayesian network model for improving safety behavior of employees at workplaces.

PubMed

Mohammadfam, Iraj; Ghasemi, Fakhradin; Kalatpour, Omid; Moghimbeigi, Abbas

2017-01-01

Unsafe behavior increases the risk of accident at workplaces and needs to be managed properly. The aim of the present study was to provide a model for managing and improving safety behavior of employees using the Bayesian networks approach. The study was conducted in several power plant construction projects in Iran. The data were collected using a questionnaire composed of nine factors, including management commitment, supporting environment, safety management system, employees' participation, safety knowledge, safety attitude, motivation, resource allocation, and work pressure. In order for measuring the score of each factor assigned by a responder, a measurement model was constructed for each of them. The Bayesian network was constructed using experts' opinions and Dempster-Shafer theory. Using belief updating, the best intervention strategies for improving safety behavior also were selected. The result of the present study demonstrated that the majority of employees do not tend to consider safety rules, regulation, procedures and norms in their behavior at the workplace. Safety attitude, safety knowledge, and supporting environment were the best predictor of safety behavior. Moreover, it was determined that instantaneous improvement of supporting environment and employee participation is the best strategy to reach a high proportion of safety behavior at the workplace. The lack of a comprehensive model that can be used for explaining safety behavior was one of the most problematic issues of the study. Furthermore, it can be concluded that belief updating is a unique feature of Bayesian networks that is very useful in comparing various intervention strategies and selecting the best one form them. Copyright © 2016 Elsevier Ltd. All rights reserved.

78 FR 69649 - North Pacific Fishery Management Council; Public Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-20

... Essential Fish Habitat (EFH) consultation update (T)) ADF&G Report (including review of Board of Fisheries...) Report Safety report from National Institute Occupational Safety & Health (NIOSH) (T) U.S. Fish and Wildlife Service (USFWS) Report Protected Species Report (including Steller Sea Lion (SSL) Environmental...

Iowa’s Comprehensive Highway Safety Plan - Review and Update : an RSPCB Peer Exchange

DOT National Transportation Integrated Search

2011-05-01

This report provides a summary of a two-part peer exchange sponsored by the Iowa Department of Transportation (Iowa DOT) and the Iowa Governors Traffic Safety Bureau (GTSB). Part one of the peer exchange offered a web conference designed to solici...

Study of application of ERTS-A imagery to fracture-related mine safety hazards in the coal mining industry

NASA Technical Reports Server (NTRS)

Wier, C. E.; Wobber, F. J.; Russell, O. R.; Martin, K. R. (Principal Investigator)

1973-01-01

The author has identified the following significant results. Mined land reclamation analysis procedures developed within the Indiana portion of the Illinois Coal Basin were independently tested in Ohio utilizing 1:80,000 scale enlargements of ERTS-1 image 1029-15361-7 (dated August 21, 1972). An area in Belmont County was selected for analysis due to the extensive surface mining and the different degrees of reclamation occurring in this area. Contour mining in this area provided the opportunity to extend techniques developed for analysis of relatively flat mining areas in Indiana to areas of rolling topography in Ohio. The analysts had no previous experience in the area. Field investigations largely confirmed office analysis results although in a few areas estimates of vegetation percentages were found to be too high. In one area this error approximated 25%. These results suggest that systematic ERTS-1 analysis in combination with selective field sampling can provide reliable vegetation percentage estimates in excess of 25% accuracy with minimum equipment investment and training. The utility of ERTS-1 for practical and reasonably reliable update of mined lands information for groups with budget limitations is suggested. Many states can benefit from low cost updates using ERTS-1 imagery from public sources.

The outcomes of recent patient safety education interventions for trainee physicians and medical students: a systematic review

PubMed Central

Kirkman, Matthew A; Sevdalis, Nick; Arora, Sonal; Baker, Paul; Vincent, Charles; Ahmed, Maria

2015-01-01

Objective To systematically review the latest evidence for patient safety education for physicians in training and medical students, updating, extending and improving on a previous systematic review on this topic. Design A systematic review. Data sources Embase, Ovid Medline and PsycINFO databases. Study selection Studies including an evaluation of patient safety training interventions delivered to trainees/residents and medical students published between January 2009 and May 2014. Data extraction The review was performed using a structured data capture tool. Thematic analysis also identified factors influencing successful implementation of interventions. Results We identified 26 studies reporting patient safety interventions: 11 involving students and 15 involving trainees/residents. Common educational content included a general overview of patient safety, root cause/systems-based analysis, communication and teamwork skills, and quality improvement principles and methodologies. The majority of courses were well received by learners, and improved patient safety knowledge, skills and attitudes. Moreover, some interventions were shown to result in positive behaviours, notably subsequent engagement in quality improvement projects. No studies demonstrated patient benefit. Availability of expert faculty, competing curricular/service demands and institutional culture were important factors affecting implementation. Conclusions There is an increasing trend for developing educational interventions in patient safety delivered to trainees/residents and medical students. However, significant methodological shortcomings remain and additional evidence of impact on patient outcomes is needed. While there is some evidence of enhanced efforts to promote sustainability of such interventions, further work is needed to encourage their wider adoption and spread. PMID:25995240

Updating of Safety Criteria for Basic Diagnostic Indicators of Dam at the Sayano-Shushenskaya HPP

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gordon, L. A.; Skvortsova, A. E.

2013-09-15

Values of diagnostic indicators [K]-limitations placed on radial displacements and turn angles of horizontal sections of the dam - which are permitted for each upper-pool level within the range from 520 to 539 m are determined and proposed for inclusion in the Declaration of Safety. Empirical relationships used to develop safety criteria K1 and K2 are modified.

The Update of the Mexican Health Care Formulary and Supply Catalog in the Context of the Health Technology Assessment.

PubMed

Ríos, Pedro Rizo; Rivera, Aurora González; Oropeza, Itzel Rivas; Ramírez, Odette Campos

2014-12-01

One of the instruments Mexico has available for the optimization of resources specifically allocated to health technologies is the Health Care Formulary and Supply Catalog (Cuadro Básico y Catálogo de Insumos del Sector Salud [CBCISS]). The aim of the CBCISS is to collaborate in the optimization of public resources through the use of technologies (supplies) that have proven their safety, therapeutic efficacy, and efficiency. The importance of the CBCISS lies in the fact that all public institutions within the National Health System must use only the established technologies it contains. The implementation of strategies that strengthen the CBCISS update process allows it to be thought of as an essential regulatory tool for the introduction of health technologies, with relevant contributions to the proper selection of cost-effective interventions. It ensures that each supply included on the list meets the criteria sufficient and necessary to ensure efficacy, safety, effectiveness, and, of course, efficiency, as evidence supporting the selection of suitable technologies. The General Health Council (Consejo de Salubridad General [CSG]) is a collegial body of constitutional origin that-in accordance with its authority-prepares, updates, publishes, and distributes the CBCISS. To perform these activities, the CSG has the CBCISS Inter-institutional Commission. The CBCISS update is performed through the processes of inclusion, modification, and exclusion of supplies approved by the Interior Commission. The CBCISS update process consists of three stages: the first stage involves a test that leads to the acceptance or inadmissibility of the requests, and the other two focus on an in-depth evaluation for the ruling. This article describes the experience of health technology assessment in Mexico, presents the achievements and outlines the improvements in the process of submission of new health technologies, and presents a preliminary analysis of the submissions evaluated until December 2012. During the analysis period, 394 submissions were received. After confirming compliance with the requirements, 59.9% of the submissions passed to the next stage of the process, technology assessment. In the third stage, the committee approved 44.9% of the submissions evaluated. The improvements established in the country in terms of health technology assessment allowed choosing the technologies that give more value for money in a context of public health institutions. Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Comparisons of ANS, ASME, AWS, and NFPA standards cited in the NRC standard review plan, NUREG-0800, and related documents

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ankrum, A.R.; Bohlander, K.L.; Gilbert, E.R.

This report provides the results of comparisons of the cited and latest versions of ANS, ASME, AWS and NFPA standards cited in the NRC Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants (NUREG 0800) and related documents. The comparisons were performed by Battelle Pacific Northwest Laboratories in support of the NRC`s Standard Review Plan Update and Development Program. Significant changes to the standards, from the cited version to the latest version, are described and discussed in a tabular format for each standard. Recommendations for updating each citation in the Standard Review Plan are presented.more » Technical considerations and suggested changes are included for related regulatory documents (i.e., Regulatory Guides and the Code of Federal Regulations) citing the standard. The results and recommendations presented in this document have not been subjected to NRC staff review.« less

Recent Updates to the MELCOR 1.8.2 Code for ITER Applications

DOE Office of Scientific and Technical Information (OSTI.GOV)

Merrill, Brad J

This report documents recent changes made to the MELCOR 1.8.2 computer code for application to the International Thermonuclear Experimental Reactor (ITER), as required by ITER Task Agreement ITA 81-18. There are four areas of change documented by this report. The first area is the addition to this code of a model for transporting HTO. The second area is the updating of the material oxidation correlations to match those specified in the ITER Safety Analysis Data List (SADL). The third area replaces a modification to an aerosol tranpsort subroutine that specified the nominal aerosol density internally with one that now allowsmore » the user to specify this density through user input. The fourth area corrected an error that existed in an air condensation subroutine of previous versions of this modified MELCOR code. The appendices of this report contain FORTRAN listings of the coding for these modifications.« less

A survey of child safety seat and safety belt use in Virginia : the 1987 update.

DOT National Transportation Integrated Search

1988-01-01

Observational surveys of belt use by the motoring public in Virginia have been conducted in two series: (1) 1974-1977 and (2) 1983-1987. Only the latter data are presented in this report. Each year data were collected in the Roanoke, Northern Virgini...

School Safety Review Checklist

ERIC Educational Resources Information Center

Vermont Department of Education, 2005

2005-01-01

The School Safety Review Checklist is an important component of the broader school crisis resources that have been developed by the Vermont School Crisis Planning Team. The Team is comprised of members from the law enforcement, emergency management, health, and education organizations who have worked throughout the year to update school and…

29 CFR 1960.69 - Retention and updating of old forms.

Code of Federal Regulations, 2010 CFR

2010-07-01

....69 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) BASIC PROGRAM ELEMENTS FOR FEDERAL EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH... continue to provide access to the data as though these forms were the OSHA Form 300 Log and Form 301...

29 CFR 1960.69 - Retention and updating of old forms.

Code of Federal Regulations, 2011 CFR

2011-07-01

....69 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) BASIC PROGRAM ELEMENTS FOR FEDERAL EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH... continue to provide access to the data as though these forms were the OSHA Form 300 Log and Form 301...

PRN 2012-1: Material Safety Data Sheets as Pesticide Labeling

EPA Pesticide Factsheets

This Notice updates and clarifies EPA’s determination in PRN 92-4 that a Material Safety Data Sheet that accompanies a pesticide product is considered part of the pesticide’s labeling but does not need EPA approval if it is consistent with 40CFR Part 156.

Fundamentally updating fundamentals.

PubMed

Armstrong, Gail; Barton, Amy

2013-01-01

Recent educational research indicates that the six competencies of the Quality and Safety Education for Nurses initiative are best introduced in early prelicensure clinical courses. Content specific to quality and safety has traditionally been covered in senior level courses. This article illustrates an effective approach to using quality and safety as an organizing framework for any prelicensure fundamentals of nursing course. Providing prelicensure students a strong foundation in quality and safety in an introductory clinical course facilitates early adoption of quality and safety competencies as core practice values. Copyright © 2013 Elsevier Inc. All rights reserved.

Guidelines for the selection of chemical protective clothing. 1991 Update: Performance, availability, and sources of chemical protective clothing

DOE Office of Scientific and Technical Information (OSTI.GOV)

Johnson, J.S.; Schwope, A.D.; Goydan, R.

1991-12-31

The selection, acquisition, and use of chemical protective clothing (CPC) at Department of Energy (DOE) facilities require up-to-date data and information on the performance, availability, and sources of such clothing. There are hundreds of types and more than one hundred principal manufacturers of CPC. Information on CPC is published in manufacturers` brochures and the technical literature. These information sources, however, have no standard format or terminology for describing products or the results of product testing. Furthermore, the literature and information is continually changing and growing. Consequently, DOE`s industrial hygienists and safety specialists are frequently confounded in their efforts to providemore » effective CPC to workers, by they in the field, the laboratory, or the plant. In recognition of the many advances and changes that have occurred and of the need to provide current information to its health and safety staff, the DOE has updated and modified the key appendices of the Guidelines/Chemical Protective Clothing. The updates appendices compose the majority of this update document, wherein they are called Sections. Each Section begins with a description of its format, content, abbreviations, units, and links with other Sections, as appropriate.« less

Open-label, multicentre safety study of vemurafenib in 3219 patients with BRAFV600 mutation-positive metastatic melanoma: 2-year follow-up data and long-term responders' analysis.

PubMed

Blank, Christian U; Larkin, James; Arance, Ana M; Hauschild, Axel; Queirolo, Paola; Del Vecchio, Michele; Ascierto, Paolo A; Krajsova, Ivana; Schachter, Jacob; Neyns, Bart; Garbe, Claus; Chiarion Sileni, Vanna; Mandalà, Mario; Gogas, Helen; Espinosa, Enrique; Hospers, Geke A P; Miller, Wilson H; Robson, Susan; Makrutzki, Martina; Antic, Vladan; Brown, Michael P

2017-07-01

The orally available BRAF kinase inhibitor vemurafenib is an effective and tolerable treatment option for patients with metastatic melanoma harbouring BRAF V600 mutations. We assessed the safety of vemurafenib in a large population of patients with few alternative treatment options; we report updated 2-year safety. This was an open-label, multicentre study of vemurafenib (960 mg bid) in patients with previously treated or untreated BRAF mutation-positive metastatic melanoma (cobas ® 4800 BRAF V600 Mutation Test). The primary end-point was safety; efficacy end-points were secondary. An exploratory analysis was performed to assess safety outcomes in patients with long duration of response (DOR) (≥12 or ≥24 months). After a median follow-up of 32.2 months (95% CI, 31.1-33.2 months), 3079/3219 patients (96%) had discontinued treatment. Adverse events (AEs) were largely consistent with previous reports; the most common all-grade treatment-related AEs were arthralgia (37%), alopecia (25%) and hyperkeratosis (23%); the most common grade 3/4 treatment-related AEs were squamous cell carcinoma of the skin (8%) and keratoacanthoma (8%). In the exploratory analysis, patients with DOR ≥12 months (n = 287) or ≥24 months (n = 133) were more likely to experience grade 3/4 AEs than the overall population. No new specific safety signals were observed with longer vemurafenib exposure. After 2 years' follow-up, safety was maintained in this large group of patients with BRAF V600 mutation-positive metastatic melanoma who are more representative of routine clinical practice than typical clinical trial populations. These data suggest that long-term vemurafenib treatment is effective and tolerable without the development of new safety signals. Copyright © 2017 Elsevier Ltd. All rights reserved.

NASA Range Safety Annual Report 2007

NASA Technical Reports Server (NTRS)

Dumont, Alan G.

2007-01-01

As always, Range Safety has been involved in a number of exciting and challenging activities and events. Throughout the year, we have strived to meet our goal of protecting the public, the workforce, and property during range operations. During the past year, Range Safety was involved in the development, implementation, and support of range safety policy. Range Safety training curriculum development was completed this year and several courses were presented. Tailoring exercises concerning the Constellation Program were undertaken with representatives from the Constellation Program, the 45th Space Wing, and the Launch Constellation Range Safety Panel. Range Safety actively supported the Range Commanders Council and it subgroups and remained involved in updating policy related to flight safety systems and flight safety analysis. In addition, Range Safety supported the Space Shuttle Range Safety Panel and addressed policy concerning unmanned aircraft systems. Launch operations at Kennedy Space Center, the Eastern and Western ranges, Dryden Flight Research Center, and Wallops Flight Facility were addressed. Range Safety was also involved in the evaluation of a number of research and development efforts, including the space-based range (formerly STARS), the autonomous flight safety system, the enhanced flight termination system, and the joint advanced range safety system. Flight safety system challenges were evaluated. Range Safety's role in the Space Florida Customer Assistance Service Program for the Eastern Range was covered along with our support for the Space Florida Educational Balloon Release Program. We hope you have found the web-based format both accessible and easy to use. Anyone having questions or wishing to have an article included in the 2008 Range Safety Annual Report should contact Alan Dumont, the NASA Range Safety Program Manager located at the Kennedy Space Center, or Michael Dook at NASA Headquarters.

Psychometrics of the AAN Caregiver Driving Safety Questionnaire and contributors to caregiver concern about driving safety in older adults.

PubMed

Carvalho, Janessa O; Springate, Beth; Bernier, Rachel A; Davis, Jennifer

2018-03-01

ABSTRACTBackground:The American Academy of Neurology (AAN) updated their practice parameters in the evaluation of driving risk in dementia and developed a Caregiver Driving Safety Questionnaire, detailed in their original manuscript (Iverson Gronseth, Reger, Classen, Dubinsky, & Rizzo, 2010). They described four factors associated with decreased driving ability in dementia patients: history of crashes or citations, informant-reported concerns, reduced mileage, and aggressive driving. An informant-reported AAN Caregiver Driving Safety Questionnaire was designed with these elements, and the current study was the first to explore the factor structure of this questionnaire. Additionally, we examined associations between these factors and cognitive and behavioral measures in patients with mild cognitive impairment or early Alzheimer's disease and their informants. Exploratory factor analysis revealed a four-component structure, consistent with the theory behind the AAN scale composition. These four factor scores also were significantly associated with performance on cognitive screening instruments and informant reported behavioral dysfunction. Regressions revealed that behavioral dysfunction predicted caregiver concerns about driving safety beyond objective patient cognitive dysfunction. In this first known quantitative exploration of the scale, our results support continued use of this scale in office driving safety assessments. Additionally, patient behavioral changes predicted caregiver concerns about driving safety over and above cognitive status, which suggests that caregivers may benefit from psychoeducation about cognitive factors that may negatively impact driving safety.

Toward an Application Guide for Safety Integrity Level Allocation in Railway Systems.

PubMed

Ouedraogo, Kiswendsida Abel; Beugin, Julie; El-Koursi, El-Miloudi; Clarhaut, Joffrey; Renaux, Dominique; Lisiecki, Frederic

2018-02-02

The work in the article presents the development of an application guide based on feedback and comments stemming from various railway actors on their practices of SIL allocation to railway safety-related functions. The initial generic methodology for SIL allocation has been updated to be applied to railway rolling stock safety-related functions in order to solve the SIL concept application issues. Various actors dealing with railway SIL allocation problems are the intended target of the methodology; its principles will be summarized in this article with a focus on modifications and precisions made in order to establish a practical guide for railway safety authorities. The methodology is based on the flowchart formalism used in CSM (common safety method) European regulation. It starts with the use of quantitative safety requirements, particularly tolerable hazard rates (THR). THR apportioning rules are applied. On the one hand, the rules are related to classical logical combinations of safety-related functions preventing hazard occurrence. On the other hand, to take into account technical conditions (last safety weak link, functional dependencies, technological complexity, etc.), specific rules implicitly used in existing practices are defined for readjusting some THR values. SIL allocation process based on apportioned and validated THR values is finally illustrated through the example of "emergency brake" subsystems. Some specific SIL allocation rules are also defined and illustrated. © 2018 Society for Risk Analysis.

Boundary condition identification for a grid model by experimental and numerical dynamic analysis

NASA Astrophysics Data System (ADS)

Mao, Qiang; Devitis, John; Mazzotti, Matteo; Bartoli, Ivan; Moon, Franklin; Sjoblom, Kurt; Aktan, Emin

2015-04-01

There is a growing need to characterize unknown foundations and assess substructures in existing bridges. It is becoming an important issue for the serviceability and safety of bridges as well as for the possibility of partial reuse of existing infrastructures. Within this broader contest, this paper investigates the possibility of identifying, locating and quantifying changes of boundary conditions, by leveraging a simply supported grid structure with a composite deck. Multi-reference impact tests are operated for the grid model and modification of one supporting bearing is done by replacing a steel cylindrical roller with a roller of compliant material. Impact based modal analysis provide global modal parameters such as damped natural frequencies, mode shapes and flexibility matrix that are used as indicators of boundary condition changes. An updating process combining a hybrid optimization algorithm and the finite element software suit ABAQUS is presented in this paper. The updated ABAQUS model of the grid that simulates the supporting bearing with springs is used to detect and quantify the change of the boundary conditions.

Updated Intensity - Duration - Frequency Curves Under Different Future Climate Scenarios

NASA Astrophysics Data System (ADS)

Ragno, E.; AghaKouchak, A.

2016-12-01

Current infrastructure design procedures rely on the use of Intensity - Duration - Frequency (IDF) curves retrieved under the assumption of temporal stationarity, meaning that occurrences of extreme events are expected to be time invariant. However, numerous studies have observed more severe extreme events over time. Hence, the stationarity assumption for extreme analysis may not be appropriate in a warming climate. This issue raises concerns regarding the safety and resilience of the existing and future infrastructures. Here we employ historical and projected (RCP 8.5) CMIP5 runs to investigate IDF curves of 14 urban areas across the United States. We first statistically assess changes in precipitation extremes using an energy-based test for equal distributions. Then, through a Bayesian inference approach for stationary and non-stationary extreme value analysis, we provide updated IDF curves based on climatic model projections. This presentation summarizes the projected changes in statistics of extremes. We show that, based on CMIP5 simulations, extreme precipitation events in some urban areas can be 20% more severe in the future, even when projected annual mean precipitation is expected to remain similar to the ground-based climatology.

Safety update on the use of recombinant activated factor VII in approved indications.

PubMed

Neufeld, Ellis J; Négrier, Claude; Arkhammar, Per; Benchikh el Fegoun, Soraya; Simonsen, Mette Duelund; Rosholm, Anders; Seremetis, Stephanie

2015-06-01

This updated safety review summarises the large body of safety data available on the use of recombinant activated factor VII (rFVIIa) in approved indications: haemophilia with inhibitors, congenital factor VII (FVII) deficiency, acquired haemophilia and Glanzmann's thrombasthenia. Accumulated data up to 31 December 2013 from clinical trials as well as post-marketing data (registries, literature reports and spontaneous reports) were included. Overall, rFVIIa has shown a consistently favourable safety profile, with no unexpected safety concerns, in all approved indications. No confirmed cases of neutralising antibodies against rFVIIa have been reported in patients with congenital haemophilia, acquired haemophilia or Glanzmann's thrombasthenia. The favourable safety profile of rFVIIa can be attributed to the recombinant nature of rFVIIa and its localised mechanism of action at the site of vascular injury. Recombinant FVIIa activates factor X directly on the surface of activated platelets, which are present only at the site of injury, meaning that systemic activation of coagulation is avoided and the risk of thrombotic events (TEs) thus reduced. Nonetheless, close monitoring for signs and symptoms of TE is warranted in all patients treated with any pro-haemostatic agent, including rFVIIa, especially the elderly and any other patients with concomitant conditions and/or predisposing risk factors to thrombosis. Copyright © 2015 Elsevier Ltd. All rights reserved.

Robotic vs. Retropubic radical prostatectomy in prostate cancer: A systematic review and a meta-analysis update

PubMed Central

Chen, Hongbo; Chen, Zhiqiang; Xu, Hua; Ye, Zhangqun

2017-01-01

CONTEXT The safety and feasibility of robotic-assisted radical prostatectomy (RARP) compared with retropubic radical prostatectomy(RRP) is debated. Recently, a number of large-scale and high-quality studies have been conducted. OBJECTIVE To obtain a more valid assessment, we update the meta-analysis of RARP compared with RRP to assessed its safety and feasibility in treatment of prostate cancer. METHODS A systematic search of Medline, Embase, Pubmed, and the Cochrane Library was performed to identify studies that compared RARP with RRP. Outcomes of interest included perioperative, pathologic variables and complications. RESULTS 78 studies assessing RARP vs. RRP were included for meta-analysis. Although patients underwent RRP have shorter operative time than RARP (WMD: 39.85 minutes; P < 0.001), patients underwent RARP have less intraoperative blood loss (WMD = -507.67ml; P < 0.001), lower blood transfusion rates (OR = 0.13; P < 0.001), shorter time to remove catheter (WMD = -3.04day; P < 0.001), shorter hospital stay (WMD = -1.62day; P < 0.001), lower PSM rates (OR:0.88; P = 0.04), fewer positive lymph nodes (OR:0.45;P < 0.001), fewer overall complications (OR:0.43; P < 0.001), higher 3- and 12-mo potent recovery rate (OR:3.19;P = 0.02; OR:2.37; P = 0.005, respectively), and lower readmission rate (OR:0.70, P = 0.03). The biochemical recurrence free survival of RARP is better than RRP (OR:1.33, P = 0.04). All the other calculated results are similar between the two groups. CONCLUSIONS Our results indicate that RARP appears to be safe and effective to its counterpart RRP in selected patients. PMID:27852051

Analysis of construction accidents in Spain, 2003-2008.

PubMed

López Arquillos, Antonio; Rubio Romero, Juan Carlos; Gibb, Alistair

2012-12-01

The research objective for this paper is to obtain a new extended and updated insight to the likely causes of construction accidents in Spain, in order to identify suitable mitigating actions. The paper analyzes all construction sector accidents in Spain between 2003 and 2008. Ten variables were chosen and the influence of each variable is evaluated with respect to the severity of the accident. The descriptive analysis is based on a total of 1,163,178 accidents. Results showed that the severity of accidents was related to variables including age, CNAE (National Classification of Economic Activities) code, size of company, length of service, location of accident, day of the week, days of absence, deviation, injury, and climatic zones. According to data analyzed, a large company is not always necessarily safer than a small company in the aspect of fatal accidents, experienced workers do not have the best accident fatality rates, and accidents occurring away from the usual workplace had more severe consequences. Results obtained in this paper can be used by companies in their occupational safety strategies, and in their safety training programs. Copyright © 2012 National Safety Council and Elsevier Ltd. All rights reserved.

A day in the life of a pharmacovigilance case processor.

PubMed

Bhangale, Ritesh; Vaity, Sayali; Kulkarni, Niranjan

2017-01-01

Pharmacovigilance (PV) has grown significantly in India in the last couple of decades. The etymological roots for the word "pharmacovigilance" are "Pharmakon" (Greek for drug) and "Vigilare" (Latin for to keep watch). It relies on information gathered from the collection of individual case safety reports and other pharmacoepidemiological data. The PV data processing cycle starts with data collection in computerized systems followed by complete data entry which includes adverse event coding, drug coding, causality and expectedness assessment, narrative writing, quality control, and report submissions followed by data storage and maintenance. A case processor plays an important role in conducting these various tasks. The case processor should also manage drug safety information, possess updated knowledge about global drug safety regulations, summarize clinical safety data, participate in meetings, write narratives with medical input from a physician, report serious adverse events to the regulatory authorities, participate in the training of operational staff on drug safety issues, quality control work of other staff in the department, and take on any other task as assigned by the manager or medical director within the capabilities of the drug safety associate. There can be challenges while handling all these tasks at a time, hence the associate will have to maintain a balance to overcome them and keep on updating their knowledge on drug safety regulations, which in turn, would help in increasing their learning curve.

Analysis of Operational Hazards and Safety Requirements for Traffic Aware Strategic Aircrew Requests (TASAR)

NASA Technical Reports Server (NTRS)

Koczo, Stefan, Jr.

2013-01-01

Safety analyses of the Traffic Aware Strategic Aircrew Requests (TASAR) Electronic Flight Bag (EFB) application are provided to establish its Failure Effects Classification which affects certification and operational approval requirements. TASAR was developed by NASA Langley Research Center to offer flight path improvement opportunities to the pilot during flight for operational benefits (e.g., reduced fuel, flight time). TASAR, using own-ship and network-enabled information concerning the flight and its environment, including weather and Air Traffic Control (ATC) system constraints, provides recommended improvements to the flight trajectory that the pilot can choose to request via Change Requests to ATC for revised clearance. This study reviews the Change Request process of requesting updates to the current clearance, examines the intended function of TASAR, and utilizes two safety assessment methods to establish the Failure Effects Classification of TASAR. Considerable attention has been given in this report to the identification of operational hazards potentially associated with TASAR.

Risk-informed Management of Water Infrastructure in the United States: History, Development, and Best Practices

NASA Astrophysics Data System (ADS)

Wolfhope, J.

2017-12-01

This presentation will focus on the history, development, and best practices for evaluating the risks associated with the portfolio of water infrastructure in the United States. These practices have evolved from the early development of the Federal Guidelines for Dam Safety and the establishment of the National Dam Safety Program, to the most recent update of the Best Practices for Dam and Levee Risk Analysis jointly published by the U.S. Department of Interior Bureau of Reclamation and the U.S. Army Corps of Engineers. Since President Obama signed the Water Infrastructure Improvements for the Nation Act (WIIN) Act, on December 16, 2016, adding a new grant program under FEMA's National Dam Safety Program, the focus has been on establishing a risk-based priority system for use in identifying eligible high hazard potential dams for which grants may be made. Finally, the presentation provides thoughts on the future direction and priorities for managing the risk of dams and levees in the United States.

Twenty-fifth water reactor safety information meeting: Proceedings. Volume 2: Human reliability analysis and human performance evaluation; Technical issues related to rulemakings; Risk-informed, performance-based initiatives; High burn-up fuel research

DOE Office of Scientific and Technical Information (OSTI.GOV)

Monteleone, S.

1998-03-01

This three-volume report contains papers presented at the conference. The papers are printed in the order of their presentation in each session and describe progress and results of programs in nuclear safety research conducted in this country and abroad. Foreign participation in the meeting included papers presented by researchers from France, Japan, Norway, and Russia. The titles of the papers and the names of the authors have been updated and may differ from those that appeared in the final program of the meeting. This volume contains the following: (1) human reliability analysis and human performance evaluation; (2) technical issues relatedmore » to rulemakings; (3) risk-informed, performance-based initiatives; and (4) high burn-up fuel research. Selected papers have been indexed separately for inclusion in the Energy Science and Technology Database.« less

Research Update - Intervention Technologies for Enhancing the Safety and Security of Fresh and Minimally Processed Produce and Solid Plant-Derived Foods

USDA-ARS?s Scientific Manuscript database

The produce safety research objectives of Research Project 1935-41420-011 are to 1) understand pathogen microbial ecology and its effects on decontamination efficacy; 2) develop biological-based intervention strategies for pathogen reduction; and 3) develop new effective chemical and physical decont...

77 FR 834 - Noise Exposure Map Update for Albany International Airport, Albany, NY

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-06

... International Airport, under the provisions of 49 U.S.C. 47501 et. seq (Aviation Safety and Noise Abatement Act... December 19, 2011. Under 49 U.S.C. section 47503 of the Aviation Safety and Noise Abatement Act... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration [Docket No. 4910-13] Noise Exposure...

75 FR 36124 - Construction Reactor Oversight Process Request for Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-24

..., and the assessment of licensee safety culture. In SECY-10-0038, ``Update Status on the Development of... commenter supports or does not support an aspect of this plan. The use of examples is encouraged. (1) The... ROP, the NRC currently assigns safety culture component aspects to findings when appropriate...

Preparing for the Update of Vermont’s Strategic Highway Safety Plan : Proceedings from the Federal Highway Administration’s Peer-to-Peer Exchange Program

DOT National Transportation Integrated Search

2011-01-01

This report provides a summary of a peer exchange sponsored by the Vermont Agency of Transportation (VTrans). The peer exchange convened Vermonts Strategic Highway Safety Plan (SHSP) Core Group to discuss the strengths and weaknesses of Vermont...

Report to Congress on the National Highway Traffic Safety Administration ITS Program : program progress during 1992-1996 and strategic plan for 1997-2002

DOT National Transportation Integrated Search

1997-01-01

Congress recently requested the Intelligent Transportation Systems (ITS) Joint Program Office and the National Highway Traffic Safety Administration to update the 1992 ITS plan to deal with the fiscal year 1997 through fiscal year 2002 period, and...

Automatic Barometric Updates from Ground-Based Navigational Aids

DTIC Science & Technology

1990-03-12

ro fAutomatic Barometric Updates US Department from of Transportation Ground-Based Federal Aviation Administration Navigational Aids Office of Safety...tighter vertical spacing controls , particularly for operations near Terminal Control Areas (TCAs), Airport Radar Service Areas (ARSAs), military climb and...E.F., Ruth, J.C., and Williges, B.H. (1987). Speech Controls and Displays. In Salvendy, G., E. Handbook of Human Factors/Ergonomics, New York, John

Significant Revisions to OSHA 29 CFR 1910.269.

PubMed

Neitzel, Dennis K

2015-06-01

The updated OSHA 29 CFR 1910.269 requirements are significant for assisting employers in their efforts to protect their employees from electrical hazards. In addition, OSHA based these revisions on the latest consensus standards and improvements in electrical safety technology. Together, the updated regulation creates a unified and up-to-date set of requirements to help employers more effectively establish safe work practices to protect their workers.

Solar Market Research and Analysis Email Updates | Solar Research | NREL

Science.gov Websites

Analysis Email Updates Solar Market Research and Analysis Email Updates NREL's Solar Market email updates, please provide and submit the following information. Email Address

Health and Safety in the Child Care Setting: Prevention of Injuries--A Curriculum for the Training of Child Care Providers. Module 2. Second Edition

ERIC Educational Resources Information Center

Zamani, A. Rahman, Ed.; Evinger, Sara, Ed.

2007-01-01

This curriculum was first published in June 1998 to be used by qualified health and safety trainers to fulfill part of the learning needs and licensing requirements of child care providers (Health and Safety Code, Section 1596.866) in California. This second and updated edition of Module 2, Prevention of Injuries, covers the content of the…

Endometrial Cancer

MedlinePlus

... Bulletins Patient Education Green Journal Clinical Updates Practice Management Coding Health Info Technology Professional Liability Managing Your Practice Patient Safety & Quality Payment Reform (MACRA) Education & Events Annual Meeting CME ...

Evaluating the U.S. Food Safety Modernization Act Produce Safety Rule Standard for Microbial Quality of Agricultural Water for Growing Produce.

PubMed

Havelaar, Arie H; Vazquez, Kathleen M; Topalcengiz, Zeynal; Muñoz-Carpena, Rafael; Danyluk, Michelle D

2017-10-09

The U.S. Food and Drug Administration (FDA) has defined standards for the microbial quality of agricultural surface water used for irrigation. According to the FDA produce safety rule (PSR), a microbial water quality profile requires analysis of a minimum of 20 samples for Escherichia coli over 2 to 4 years. The geometric mean (GM) level of E. coli should not exceed 126 CFU/100 mL, and the statistical threshold value (STV) should not exceed 410 CFU/100 mL. The water quality profile should be updated by analysis of a minimum of five samples per year. We used an extensive set of data on levels of E. coli and other fecal indicator organisms, the presence or absence of Salmonella, and physicochemical parameters in six agricultural irrigation ponds in West Central Florida to evaluate the empirical and theoretical basis of this PSR. We found highly variable log-transformed E. coli levels, with standard deviations exceeding those assumed in the PSR by up to threefold. Lognormal distributions provided an acceptable fit to the data in most cases but may underestimate extreme levels. Replacing censored data with the detection limit of the microbial tests underestimated the true variability, leading to biased estimates of GM and STV. Maximum likelihood estimation using truncated lognormal distributions is recommended. Twenty samples are not sufficient to characterize the bacteriological quality of irrigation ponds, and a rolling data set of five samples per year used to update GM and STV values results in highly uncertain results and delays in detecting a shift in water quality. In these ponds, E. coli was an adequate predictor of the presence of Salmonella in 150-mL samples, and turbidity was a second significant variable. The variability in levels of E. coli in agricultural water was higher than that anticipated when the PSR was finalized, and more detailed information based on mechanistic modeling is necessary to develop targeted risk management strategies.

WHO Working Group on revision of the Manual of Laboratory Methods for Testing DTP Vaccines-Report of two meetings held on 20-21 July 2006 and 28-30 March 2007, Geneva, Switzerland.

PubMed

Corbel, Michael J; Das, Rose Gaines; Lei, Dianliang; Xing, Dorothy K L; Horiuchi, Yoshinobu; Dobbelaer, Roland

2008-04-07

This report reflects the discussion and conclusions of a WHO group of experts from National Regulatory Authorities (NRAs), National Control Laboratories (NCLs), vaccine industries and other relevant institutions involved in standardization and control of diphtheria, tetanus and pertussis vaccines (DTP), held on 20-21 July 2006 and 28-30 March 2007, in Geneva Switzerland for the revision of WHO Manual for quality control of DTP vaccines. Taking into account recent developments and standardization in quality control methods and the revision of WHO recommendations for D, T, P vaccines, and a need for updating the manual has been recognized. In these two meetings the current situation of quality control methods in terms of potency, safety and identity tests for DTP vaccines and statistical analysis of data were reviewed. Based on the WHO recommendations and recent validation of testing methods, the content of current manual were reviewed and discussed. The group agreed that the principles to be observed in selecting methods included identifying those critical for assuring safety, efficacy and quality and which were consistent with WHO recommendations/requirements. Methods that were well recognized but not yet included in current Recommendations should be taken into account. These would include in vivo and/or in vitro methods for determining potency, safety testing and identity. The statistical analysis of the data should be revised and updated. It was noted that the mouse based assays for toxoid potency were still quite widely used and it was desirable to establish appropriate standards for these to enable the results to be related to the standard guinea pig assays. The working group was met again to review the first drafts and to input further suggestions or amendments to the contributions of the drafting groups. The revised manual was to be finalized and published by WHO.

Rapid Classification and Identification of Multiple Microorganisms with Accurate Statistical Significance via High-Resolution Tandem Mass Spectrometry

NASA Astrophysics Data System (ADS)

Alves, Gelio; Wang, Guanghui; Ogurtsov, Aleksey Y.; Drake, Steven K.; Gucek, Marjan; Sacks, David B.; Yu, Yi-Kuo

2018-06-01

Rapid and accurate identification and classification of microorganisms is of paramount importance to public health and safety. With the advance of mass spectrometry (MS) technology, the speed of identification can be greatly improved. However, the increasing number of microbes sequenced is complicating correct microbial identification even in a simple sample due to the large number of candidates present. To properly untwine candidate microbes in samples containing one or more microbes, one needs to go beyond apparent morphology or simple "fingerprinting"; to correctly prioritize the candidate microbes, one needs to have accurate statistical significance in microbial identification. We meet these challenges by using peptide-centric representations of microbes to better separate them and by augmenting our earlier analysis method that yields accurate statistical significance. Here, we present an updated analysis workflow that uses tandem MS (MS/MS) spectra for microbial identification or classification. We have demonstrated, using 226 MS/MS publicly available data files (each containing from 2500 to nearly 100,000 MS/MS spectra) and 4000 additional MS/MS data files, that the updated workflow can correctly identify multiple microbes at the genus and often the species level for samples containing more than one microbe. We have also shown that the proposed workflow computes accurate statistical significances, i.e., E values for identified peptides and unified E values for identified microbes. Our updated analysis workflow MiCId, a freely available software for Microorganism Classification and Identification, is available for download at https://www.ncbi.nlm.nih.gov/CBBresearch/Yu/downloads.html.

Rapid Classification and Identification of Multiple Microorganisms with Accurate Statistical Significance via High-Resolution Tandem Mass Spectrometry.

PubMed

Alves, Gelio; Wang, Guanghui; Ogurtsov, Aleksey Y; Drake, Steven K; Gucek, Marjan; Sacks, David B; Yu, Yi-Kuo

2018-06-05

Rapid and accurate identification and classification of microorganisms is of paramount importance to public health and safety. With the advance of mass spectrometry (MS) technology, the speed of identification can be greatly improved. However, the increasing number of microbes sequenced is complicating correct microbial identification even in a simple sample due to the large number of candidates present. To properly untwine candidate microbes in samples containing one or more microbes, one needs to go beyond apparent morphology or simple "fingerprinting"; to correctly prioritize the candidate microbes, one needs to have accurate statistical significance in microbial identification. We meet these challenges by using peptide-centric representations of microbes to better separate them and by augmenting our earlier analysis method that yields accurate statistical significance. Here, we present an updated analysis workflow that uses tandem MS (MS/MS) spectra for microbial identification or classification. We have demonstrated, using 226 MS/MS publicly available data files (each containing from 2500 to nearly 100,000 MS/MS spectra) and 4000 additional MS/MS data files, that the updated workflow can correctly identify multiple microbes at the genus and often the species level for samples containing more than one microbe. We have also shown that the proposed workflow computes accurate statistical significances, i.e., E values for identified peptides and unified E values for identified microbes. Our updated analysis workflow MiCId, a freely available software for Microorganism Classification and Identification, is available for download at https://www.ncbi.nlm.nih.gov/CBBresearch/Yu/downloads.html . Graphical Abstract ᅟ.

Stringency of workplace air contaminant exposure limits: a case study of OSHA risk management.

PubMed

Hakes, J K

1999-12-01

Political context may play a large role in influencing the efficiency of environmental and health regulations. This case study uses data from a 1989 update of the Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs) program to determine the relative effects of legislative mandates, costly acquisition of information by the agency, and pressure applied by special interest groups upon exposure standards. The empirical analysis suggests that federal agencies successfully thwart legislative attempts to limit agency discretion, and that agencies exercise bounded rationality by placing greater emphasis on more easily obtained information. The 1989 PELs were less significantly related to more costly information, contained "safety factors" for chemicals presenting relatively more ambiguous risks, and the proposed standard stringencies showed evidence of being influenced by vying industry and labor interests.

Evaluation of liquefaction potential for building code

NASA Astrophysics Data System (ADS)

Nunziata, C.; De Nisco, G.; Panza, G. F.

2008-07-01

The standard approach for the evaluation of the liquefaction susceptibility is based on the estimation of a safety factor between the cyclic shear resistance to liquefaction and the earthquake induced shear stress. Recently, an updated procedure based on shear-wave velocities (Vs) has been proposed which could be more easily applied. These methods have been applied at La Plaja beach of Catania, that experienced liquefaction because of the 1693 earthquake. The detailed geotechnical and Vs information and the realistic ground motion computed for the 1693 event let us compare the two approaches. The successful application of the Vs procedure, slightly modified to fit historical and safety factor information, even if additional field performances are needed, encourages the development of a guide for liquefaction potential analysis, based on well defined Vs profiles to be included in the italian seismic code.

Supplemental Thermal-Hydraulic Transient Analyses of BR2 in Support of Conversion to LEU Fuel

DOE Office of Scientific and Technical Information (OSTI.GOV)

Licht, J.; Dionne, B.; Sikik, E.

2016-01-01

Belgian Reactor 2 (BR2) is a research and test reactor located in Mol, Belgium and is primarily used for radioisotope production and materials testing. The Materials Management and Minimization (M3) Reactor Conversion Program of the National Nuclear Security Administration (NNSA) is supporting the conversion of the BR2 reactor from Highly Enriched Uranium (HEU) fuel to Low Enriched Uranium (LEU) fuel. The RELAP5/Mod 3.3 code has been used to perform transient thermal-hydraulic safety analyses of the BR2 reactor to support reactor conversion. A RELAP5 model of BR2 has been validated against select transient BR2 reactor experiments performed in 1963 by showingmore » agreement with measured cladding temperatures. Following the validation, the RELAP5 model was then updated to represent the current use of the reactor; taking into account core configuration, neutronic parameters, trip settings, component changes, etc. Simulations of the 1963 experiments were repeated with this updated model to re-evaluate the boiling risks associated with the currently allowed maximum heat flux limit of 470 W/cm 2 and temporary heat flux limit of 600 W/cm 2. This document provides analysis of additional transient simulations that are required as part of a modern BR2 safety analysis report (SAR). The additional simulations included in this report are effect of pool temperature, reduced steady-state flow rate, in-pool loss of coolant accidents, and loss of external cooling. The simulations described in this document have been performed for both an HEU- and LEU-fueled core.« less

Exercise during Pregnancy

MedlinePlus

... Bulletins Patient Education Green Journal Clinical Updates Practice Management Coding Health Info Technology Professional Liability Managing Your Practice Patient Safety & Quality Payment Reform (MACRA) Education & Events Annual Meeting CME ...

Dysmenorrhea: Painful Periods

MedlinePlus

... Journal Clinical Updates Practice Management Coding Health Info Technology Professional Liability Managing Your Practice Patient Safety & Quality Payment Reform (MACRA) Education & Events Annual Meeting CME Overview CREOG Meetings Calendar ...

HFE Process Guidance and Standards for potential application to updating NRC guidance

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jacques Hugo; J. J. Persensky

2012-07-01

The U.S. Nuclear Regulatory Commission (NRC) reviews and evaluates the human factors engineering (HFE) programs of applicants for nuclear power plant construction permits, operating licenses, standard design certifications, and combined operating licenses. The purpose of these safety reviews is to help ensure that personnel performance and reliability are appropriately supported. Detailed design review procedures and guidance for the evaluations is provided in three key documents: the Standard Review Plan (NUREG-0800), the HFE Program Review Model (NUREG-0711), and the Human-System Interface Design Review Guidelines (NUREG-0700). These documents were last revised in 2007, 2004 and 2002, respectively. The NRC is committed tomore » the periodic update and improvement of these guidance documents to ensure that they remain state-of-the-art design evaluation tools. Thus, the NRC has initiated a project with BNL to update the NRC guidance to remain current with recent research on human performance, advances in HFE methods and tools, and new technology. INL supported Brookhaven National Lab (BNL) to update the detailed HFE review criteria contained in NUREG-0711 and NUREG-0700 based on (1) feedback obtained from end users, (2) the results of NRC research and development efforts supporting the NRC staff’s HFE safety reviews, and (3) other material the project staff identify as applicable to the update effort. INL submitted comments on development plans and sections of NUREGs 0800, 0711, and 0700. The contractor prepared the report attached here as the deliverable for this work.« less

TA 55 Reinvestment Project II Phase C Update Project Status May 23, 2017

DOE Office of Scientific and Technical Information (OSTI.GOV)

Giordano, Anthony P.

The TA-55 Reinvestment Project (TRP) II Phase C is a critical infrastructure project focused on improving safety and reliability of the Los Alamos National Laboratory (LANL) TA-55 Complex. The Project recapitalizes and revitalizes aging and obsolete facility and safety systems providing a sustainable nuclear facility for National Security Missions.

Indicators of School Crime and Safety: 2010. NCES 2011-002/NCJ 230812

ERIC Educational Resources Information Center

Robers, Simone; Zhang, Jijun; Truman, Jennifer

2010-01-01

Ensuring safer schools requires establishing good indicators of the current state of school crime and safety across the nation and regularly updating and monitoring these indicators. This is the aim of this report. This report is the thirteenth in a series of annual publications produced jointly by the National Center for Education Statistics…

Media and Body Image

MedlinePlus

... Bulletins Patient Education Green Journal Clinical Updates Practice Management Coding Health Info Technology Professional Liability Managing Your Practice Patient Safety & Quality Payment Reform (MACRA) Education & Events Annual Meeting CME ...

Parametric Criticality Safety Calculations for Arrays of TRU Waste Containers

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gough, Sean T.

The Nuclear Criticality Safety Division (NCSD) has performed criticality safety calculations for finite and infinite arrays of transuranic (TRU) waste containers. The results of these analyses may be applied in any technical area onsite (e.g., TA-54, TA-55, etc.), as long as the assumptions herein are met. These calculations are designed to update the existing reference calculations for waste arrays documented in Reference 1, in order to meet current guidance on calculational methodology.

Efficacy and safety of biological and targeted-synthetic DMARDs: a systematic literature review informing the 2016 update of the ASAS/EULAR recommendations for the management of axial spondyloarthritis

PubMed Central

Regel, Andrea; van der Heijde, Désirée; Braun, Jürgen; Baraliakos, Xenofon; Landewé, Robert; Van den Bosch, Filip; Falzon, Louise; Ramiro, Sofia

2017-01-01

Objectives To update the evidence for the efficacy and safety of (b)biological and (ts)targeted-synthetic disease-modifying anti-rheumatic drugs (DMARDs) in patients with axial spondyloarthritis (axSpA) to inform the 2016 update of the Assessment of SpondyloArthritis international Society/European League Against Rheumatism (ASAS/EULAR) recommendations for the management of axSpA. Methods Systematic literature review (2009–2016) for randomised controlled trials (RCT), including long-term extensions, strategy trials and observational studies (the latter was only for safety assessment and a comparator was required). Interventions were any bDMARD or tsDMARD. All relevant efficacy and safety outcomes were included. Results 76 papers and 24 abstracts fulfilled the inclusion criteria. Large treatment effects were found both in radiographic axSpA (r-axSpA) and non-radiographic axSpA (nr-axSpA) for all tumour necrosis factor inhibitors (TNFi) (NNT to achieve ASAS40 response ranged between 2.6–5.2 for r-axSpA and 2.3–5.4 for nr-axSpA). For nr-axSpA, efficacy was superior for those who had objective signs of inflammation (positive C reactive protein or inflammation on MRI-SI). Secukinumab 150 mg has shown efficacy in two phase 3 RCTs (NNT to achieve ASAS40 response: 3.4 and 4.0). Ustekinumab and tofacitinib have shown positive results in phase 2/proof-of-concept trials; trials with apremilast, rituximab, interleukin (IL)-6 antagonists and abatacept have failed their primary end points. New (unknown) safety signals were not found in the trials but long-term observational safety data for TNFi are still scarce. Conclusions New evidence supports the efficacy and safety of TNFi both in r-axSpA and nr-axSpA. Secukinumab is the first drug targeting the IL-17 pathway in r-axSpA that has shown efficacy. PMID:28176964

Updates to building-code maps for the 2015 NEHRP recommended seismic provisions

USGS Publications Warehouse

Luco, Nicolas; Bachman, Robert; Crouse, C.B; Harris, James R.; Hooper, John D.; Kircher, Charles A.; Caldwell, Phillp; Rukstales, Kenneth S.

2015-01-01

With the 2014 update of the U.S. Geological Survey (USGS) National Seismic Hazard Model (NSHM) as a basis, the Building Seismic Safety Council (BSSC) has updated the earthquake ground motion maps in the National Earthquake Hazards Reduction Program (NEHRP) Recommended Seismic Provisions for New Buildings and Other Structures, with partial funding from the Federal Emergency Management Agency. Anticipated adoption of the updated maps into the American Society of Civil Engineers Minimum Design Loads for Building and Other Structures and the International Building and Residential Codes is underway. Relative to the ground motions in the prior edition of each of these documents, most of the updated values are within a ±20% change. The larger changes are, in most cases, due to the USGS NSHM updates, reasons for which are given in companion publications. In some cases, the larger changes are partly due to a BSSC update of the slope of the fragility curve that is used to calculate the risk-targeted ground motions, and/or the introduction by BSSC of a quantitative definition of “active faults” used to calculate deterministic ground motions.

Soil Fumigant Labels - Dazomet

EPA Pesticide Factsheets

Updated labels include new safety requirements for buffer zones and related measures. Find information from the Pesticide Product Labeling System (PPLS) for products such as Basamid G, manufactured by Amvac.

Identification of an updated set of prescribing-safety indicators for GPs

PubMed Central

Spencer, Rachel; Bell, Brian; Avery, Anthony J; Gookey, Gill; Campbell, Stephen M

2014-01-01

Background Medication error is an important contributor to patient morbidity and mortality and is associated with inadequate patient safety measures. However, prescribing-safety tools specifically designed for use in general practice are lacking. Aim To identify and update a set of prescribing-safety indicators for assessing the safety of prescribing in general practice, and to estimate the risk of harm to patients associated with each indicator. Design and setting RAND/UCLA consensus development of indicators in UK general practice. Method Prescribing indicators were identified from a systematic review and previous consensus exercise. The RAND Appropriateness Method was used to further identify and develop the indicators with an electronic-Delphi method used to rate the risk associated with them. Twelve GPs from all the countries of the UK participated in the RAND exercise, with 11 GPs rating risk using the electronic-Delphi approach. Results Fifty-six prescribing-safety indicators were considered appropriate for inclusion (overall panel median rating of 7–9, with agreement). These indicators cover hazardous prescribing across a range of therapeutic indications, hazardous drug–drug combinations and inadequate laboratory test monitoring. Twenty-three (41%) of these indicators were considered high risk or extreme risk by 80% or more of the participants. Conclusion This study identified a set of 56 indicators that were considered, by a panel of GPs, to be appropriate for assessing the safety of GP prescribing. Twenty-three of these indicators were considered to be associated with high or extreme risk to patients and should be the focus of efforts to improve patient safety. PMID:24686882

A Mixed-Methods Study of Patient-Provider E-mail Content in a Safety-Net Setting

PubMed Central

Mirsky, Jacob B.; Tieu, Lina; Lyles, Courtney; Sarkar, Urmimala

2016-01-01

Objective To explore the content of patient-provider e-mails in a safety-net primary care clinic. Methods We conducted a content analysis using inductive and deductive coding of e-mail exchanges (n=31) collected from January through November of 2013. Participants were English-speaking adult patients with a chronic condition (or their caregivers) cared for at a single publicly-funded general internal medicine clinic and their primary care providers (attending general internist physicians, clinical fellows, internal medicine residents, and nurse practitioners). Results All e-mails were non-urgent. Patients included a medical update in 19% of all e-mails. Patients requested action in 77% of e-mails, and the most common requests overall were for action regarding medications or treatment (29%). Requests for information were less common (45% of e-mails). Patient requests (n=56) were resolved in 84% of e-mail exchanges, resulting in 63 actions. Conclusion Patients in safety-net clinics are capable of safely and effectively using electronic messaging for between-visit communication with providers. Practical Implications Safety-net systems should implement electronic communications tools as soon as possible to increase healthcare access and enhance patient involvement in their care. PMID:26332306

Staying Active: Physical Activity and Exercise

MedlinePlus

... Bulletins Patient Education Green Journal Clinical Updates Practice Management Coding Health Info Technology Professional Liability Managing Your Practice Patient Safety & Quality Payment Reform (MACRA) Education & Events Annual Meeting CME ...

Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: final update of the pivotal ERIVANCE BCC study.

PubMed

Sekulic, Aleksandar; Migden, Michael R; Basset-Seguin, Nicole; Garbe, Claus; Gesierich, Anja; Lao, Christopher D; Miller, Chris; Mortier, Laurent; Murrell, Dedee F; Hamid, Omid; Quevedo, Jorge F; Hou, Jeannie; McKenna, Edward; Dimier, Natalie; Williams, Sarah; Schadendorf, Dirk; Hauschild, Axel

2017-05-16

In the primary analysis of the ERIVANCE BCC trial, vismodegib, the first US Food and Drug Administration-approved Hedgehog pathway inhibitor, showed objective response rates (ORRs) by independent review facility (IRF) of 30% and 43% in metastatic basal cell carcinoma (mBCC) and locally advanced BCC (laBCC), respectively. ORRs by investigator review were 45% (mBCC) and 60% (laBCC). Herein, we present long-term safety and final investigator-assessed efficacy results in patients with mBCC or laBCC. One hundred four patients with measurable advanced BCC received oral vismodegib 150 mg once daily until disease progression or intolerable toxicity. The primary end point was IRF-assessed ORR. Secondary end points included ORR, duration of response (DOR), progression-free survival, overall survival (OS), and safety. At data cutoff (39 months after completion of accrual), 8 patients were receiving the study drug (69 patients in survival follow-up). Investigator-assessed ORR was 48.5% in the mBCC group (all partial responses) and 60.3% in the laBCC group (20 patients had complete response and 18 patients had partial response). ORRs were comparable across patient subgroups, including aggressive histologic subtypes (eg, infiltrative BCC). Median DOR was 14.8 months (mBCC) and 26.2 months (laBCC). Median OS was 33.4 months in the mBCC cohort and not estimable in the laBCC cohort. Adverse events remained consistent with clinical experience. Thirty-three deaths (31.7%) were reported; none were related to vismodegib. This long-term update of the ERIVANCE BCC trial demonstrated durability of response, efficacy across patient subgroups, and manageable long-term safety of vismodegib in patients with advanced BCC. This study was registered prospectively with Clinicaltrials.gov , number NCT00833417 on January 30, 2009.

Contrast induced nephropathy: updated ESUR Contrast Media Safety Committee guidelines.

PubMed

Stacul, Fulvio; van der Molen, Aart J; Reimer, Peter; Webb, Judith A W; Thomsen, Henrik S; Morcos, Sameh K; Almén, Torsten; Aspelin, Peter; Bellin, Marie-France; Clement, Olivier; Heinz-Peer, Gertraud

2011-12-01

The Contrast Media Safety Committee (CMSC) of the European Society of Urogenital Radiology (ESUR) has updated its 1999 guidelines on contrast medium-induced nephropathy (CIN). Topics reviewed include the definition of CIN, the choice of contrast medium, the prophylactic measures used to reduce the incidence of CIN, and the management of patients receiving metformin. Key Points • Definition, risk factors and prevention of contrast medium induced nephropathy are reviewed. • CIN risk is lower with intravenous than intra-arterial iodinated contrast medium. • eGFR of 45 ml/min/1.73 m (2) is CIN risk threshold for intravenous contrast medium. • Hydration with either saline or sodium bicarbonate reduces CIN incidence. • Patients with eGFR ≥ 60 ml/min/1.73 m (2) receiving contrast medium can continue metformin normally.

Technical books and monographs. 1977 catalog

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

Books and monographs sponsored by the Energy Research and Development Administration (ERDA) and by the organizations brought together to form ERDA under the Energy Reorganization Act of 1974 are listed. In general, information for each published book, and for each book in press when known, includes title; author and author affiliation; publisher and publication date; page count; size of book; price; availability information if the book is not available from the publisher; Library of Congress card number (LC); International Standard Book Number (ISBN); a brief descriptive statement concerning the book; and for the more recent books a list or amore » description of the contents. The books and monographs are grouped under thirteen subject categories. Recent published symposiums from ERDA projects and recent and relevant bibliographies appear in special sections at the end of each subject category. Also, at the end of the catalog are described the following ERDA publications: ERDA Energy Research Abstracts, Energy Abstracts for Policy Analysis, Solar Energy Update, Fossil Energy Update, Nuclear Safety, and Power Reactor Docket Information.« less

Advanced Reactor PSA Methodologies for System Reliability Analysis and Source Term Assessment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Grabaskas, D.; Brunett, A.; Passerini, S.

Beginning in 2015, a project was initiated to update and modernize the probabilistic safety assessment (PSA) of the GE-Hitachi PRISM sodium fast reactor. This project is a collaboration between GE-Hitachi and Argonne National Laboratory (Argonne), and funded in part by the U.S. Department of Energy. Specifically, the role of Argonne is to assess the reliability of passive safety systems, complete a mechanistic source term calculation, and provide component reliability estimates. The assessment of passive system reliability focused on the performance of the Reactor Vessel Auxiliary Cooling System (RVACS) and the inherent reactivity feedback mechanisms of the metal fuel core. Themore » mechanistic source term assessment attempted to provide a sequence specific source term evaluation to quantify offsite consequences. Lastly, the reliability assessment focused on components specific to the sodium fast reactor, including electromagnetic pumps, intermediate heat exchangers, the steam generator, and sodium valves and piping.« less

Staff nurses as antimicrobial stewards: An integrative literature review.

PubMed

Monsees, Elizabeth; Goldman, Jennifer; Popejoy, Lori

2017-08-01

Guidelines on antimicrobial stewardship emphasize the importance of an interdisciplinary team, but current practice focuses primarily on defining the role of infectious disease physicians and pharmacists; the role of inpatient staff nurses as antimicrobial stewards is largely unexplored. An updated integrative review method guided a systematic appraisal of 13 articles spanning January 2007-June 2016. Quantitative and qualitative peer-reviewed publications including staff nurses and antimicrobial knowledge or stewardship were incorporated into the analysis. Two predominant themes emerged from this review: (1) nursing knowledge, education, and information needs; and (2) patient safety and organizational factors influencing antibiotic management. Focused consideration to empower and educate staff nurses in antimicrobial management is needed to strengthen collaboration and build an interprofessional stewardship workforce. Further exploration on the integration and measurement of nursing participation is needed to accelerate this important patient safety initiative. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Developing a Framework for Evaluating the Patient Engagement, Quality, and Safety of Mobile Health Applications.

PubMed

Singh, Karandeep; Drouin, Kaitlin; Newmark, Lisa P; Rozenblum, Ronen; Lee, Jaeho; Landman, Adam; Pabo, Erika; Klinger, Elissa V; Bates, David W

2016-02-01

Rising ownership of smartphones and tablets across social and demographic groups has made mobile applications, or apps, a potentially promising tool for engaging patients in their health care, particularly those with high health care needs. Through a systematic search of iOS (Apple) and Android app stores and an analysis of apps targeting individuals with chronic illnesses, we assessed the degree to which apps are likely to be useful in patient engagement efforts. Usefulness was determined based on the following criteria: description of engagement, relevance to the targeted patient population, consumer ratings and reviews, and most recent app update. Among the 1,046 health care-related, patient-facing applications identified by our search, 43 percent of iOS apps and 27 percent of Android apps appeared likely to be useful. We also developed criteria for evaluating the patient engagement, quality, and safety of mobile apps.

Damage severity assessment in wind turbine blade laboratory model through fuzzy finite element model updating

NASA Astrophysics Data System (ADS)

Turnbull, Heather; Omenzetter, Piotr

2017-04-01

The recent shift towards development of clean, sustainable energy sources has provided a new challenge in terms of structural safety and reliability: with aging, manufacturing defects, harsh environmental and operational conditions, and extreme events such as lightning strikes wind turbines can become damaged resulting in production losses and environmental degradation. To monitor the current structural state of the turbine, structural health monitoring (SHM) techniques would be beneficial. Physics based SHM in the form of calibration of a finite element model (FEMs) by inverse techniques is adopted in this research. Fuzzy finite element model updating (FFEMU) techniques for damage severity assessment of a small-scale wind turbine blade are discussed and implemented. The main advantage is the ability of FFEMU to account in a simple way for uncertainty within the problem of model updating. Uncertainty quantification techniques, such as fuzzy sets, enable a convenient mathematical representation of the various uncertainties. Experimental frequencies obtained from modal analysis on a small-scale wind turbine blade were described by fuzzy numbers to model measurement uncertainty. During this investigation, damage severity estimation was investigated through addition of small masses of varying magnitude to the trailing edge of the structure. This structural modification, intended to be in lieu of damage, enabled non-destructive experimental simulation of structural change. A numerical model was constructed with multiple variable additional masses simulated upon the blades trailing edge and used as updating parameters. Objective functions for updating were constructed and minimized using both particle swarm optimization algorithm and firefly algorithm. FFEMU was able to obtain a prediction of baseline material properties of the blade whilst also successfully predicting, with sufficient accuracy, a larger magnitude of structural alteration and its location.

Acellular vaccines for preventing whooping cough in children.

PubMed

Zhang, Linjie; Prietsch, Sílvio O M; Axelsson, Inge; Halperin, Scott A

2014-09-17

Routine use of whole-cell pertussis (wP) vaccines was suspended in some countries in the 1970s and 1980s because of concerns about adverse effects. Following this action, there was a resurgence of whooping cough. Acellular pertussis (aP) vaccines, containing purified or recombinant Bordetella pertussis (B. pertussis) antigens, were developed in the hope that they would be as effective, but less reactogenic than the whole-cell vaccines. This is an update of a Cochrane review first published in 1999, and previously updated in 2012. In this update, we included no new studies. To assess the efficacy and safety of acellular pertussis vaccines in children and to compare them with the whole-cell vaccines. We searched CENTRAL (2013, Issue 12), MEDLINE (1950 to January week 2, 2014), EMBASE (1974 to January 2014), Biosis Previews (2009 to January 2014) and CINAHL (2009 to January 2014). We selected double-blind randomised efficacy and safety trials of aP vaccines in children up to six years old, with active follow-up of participants and laboratory verification of pertussis cases. Two review authors independently extracted data and assessed the risk of bias in the studies. Differences in trial design precluded a meta-analysis of the efficacy data. We pooled the safety data from individual trials using a random-effects meta-analysis model. We included six efficacy trials with a total of 46,283 participants and 52 safety trials with a total of 136,541 participants. Most of the safety trials did not report the methods for random sequence generation, allocation concealment and blinding, which made it difficult to assess the risk of bias in the studies. The efficacy of multi-component (≥ three) vaccines varied from 84% to 85% in preventing typical whooping cough (characterised by 21 or more consecutive days of paroxysmal cough with confirmation of B. pertussis infection by culture, appropriate serology or contact with a household member who has culture-confirmed pertussis), and from 71% to 78% in preventing mild pertussis disease (characterised by seven or more consecutive days of cough with confirmation of B. pertussis infection by culture or appropriate serology). In contrast, the efficacy of one- and two-component vaccines varied from 59% to 78% against typical whooping cough and from 41% to 58% against mild pertussis disease. Multi-component acellular vaccines are more effective than low-efficacy whole-cell vaccines, but may be less effective than the highest-efficacy whole-cell vaccines. Most systemic and local adverse events were significantly less common with aP vaccines than with wP vaccines for the primary series as well as for the booster dose. Multi-component (≥ three) aP vaccines are effective in preventing whooping cough in children. Multi-component aP vaccines have higher efficacy than low-efficacy wP vaccines, but they may be less efficacious than the highest-efficacy wP vaccines. Acellular vaccines have fewer adverse effects than whole-cell vaccines for the primary series as well as for booster doses.

Hazardous materials

MedlinePlus

... should be in a room with good airflow Work Safely If you find a spill, treat it like ... Updated April 10, 2017. Accessed February 21, 2018. Occupational Safety and Health Administration website. Healthcare. www.osha.gov/ ...

Updating the landscape of direct-to-consumer pharmacogenomic testing.

PubMed

Filipski, Kelly K; Murphy, John D; Helzlsouer, Kathy J

2017-01-01

Pharmacogenomics has identified important drug-gene interactions that affect the safety and efficacy of medications. Direct-to-consumer genetic testing, when first introduced, included some pharmacogenomic-related genes. The current landscape of pharmacogenomic direct-to-consumer testing is reviewed. Prior published reviews of the literature were updated through February 2017 and a scan of the current availability of direct-to-consumer genomic testing by companies was conducted. Results of the review demonstrate a shift toward physician-approved ordering.

Simvastatin prescribing patterns before and after FDA dosing restrictions: a retrospective analysis of a large healthcare claims database.

PubMed

Tuchscherer, Rhianna M; Nair, Kavita; Ghushchyan, Vahram; Saseen, Joseph J

2015-02-01

Muscle-related events, or myopathies, are a commonly reported adverse event associated with statin use. In June 2011, the US FDA released a Drug Safety Communication that provided updated product labeling with dosing restrictions for simvastatin to minimize the risk of myopathies. Our objective was to describe prescribing patterns of simvastatin in combination with medications known to increase the risk of myopathies following updated product labeling dosing restrictions in June 2011. A retrospective observational analysis was carried out, in which administrative claims data were utilized to identify prescribing patterns of simvastatin in combination with calcium channel blockers (CCBs) and other pre-specified drug therapies. Prescribing patterns were analyzed on a monthly basis 24 months prior to and 9 months following product label changes. Incidence of muscle-related events was also analyzed. In June 2011, a total of 60% of patients with overlapping simvastatin-CCB claims and 94% of patients with overlapping simvastatin-non-CCB claims were prescribed an against-label combination. As of March 2012, a total of 41% and 93% of patients continued to be prescribed against-label simvastatin-CCB and simvastatin-non-CCB combinations, respectively. The most commonly prescribed dose of simvastatin was 20 mg (39%). Against-label combinations were most commonly prescribed at a simvastatin dose of 40 mg (56%). Amlodipine was the most commonly prescribed CCB in combination with simvastatin (70%) and the most common CCB prescribed against-label (67%). Despite improvements in prescribing practices, many patients are still exposed to potentially harmful simvastatin combinations. Aggressive changes in simvastatin prescribing systems and processes are needed to improve compliance with FDA labeling to improve medication and patient safety.

Frostbite

MedlinePlus

... Preventing Frostbite To help prevent frostbite in cold weather: Stay updated on weather forecasts. If it's extremely cold, even brief exposure ... Medical History Cold, Ice, and Snow Safety Cold-Weather Sports and Your Family First-Aid Kit What ...

Flame Retardants Used in Flexible Polyurethane Foam

EPA Pesticide Factsheets

The partnership project on flame retardants in furniture seeks to update the health and environmental profiles of flame-retardant chemicals that meet fire safety standards for upholstered consumer products with polyurethane foam

75 FR 5353 - Sunshine Act Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-02

... Safety Improvements, February 2010 Progress Report and Update on Federal Issues. News Media Contact... archived webcast by accessing a link under ``News & Events'' on the NTSB home page at http://www.ntsb.gov...

47 CFR 80.409 - Station logs.

Code of Federal Regulations, 2013 CFR

2013-10-01

..., the Officer of the Navigational Watch, or GMDSS Operator on watch, shall update the embedded position... (vessels subject to the Global Maritime Distress and Safety System (GMDSS) should also refer to subpart W...

47 CFR 80.409 - Station logs.

Code of Federal Regulations, 2014 CFR

2014-10-01

..., the Officer of the Navigational Watch, or GMDSS Operator on watch, shall update the embedded position... (vessels subject to the Global Maritime Distress and Safety System (GMDSS) should also refer to subpart W...

Object-Oriented MDAO Tool with Aeroservoelastic Model Tuning Capability

NASA Technical Reports Server (NTRS)

Pak, Chan-gi; Li, Wesley; Lung, Shun-fat

2008-01-01

An object-oriented multi-disciplinary analysis and optimization (MDAO) tool has been developed at the NASA Dryden Flight Research Center to automate the design and analysis process and leverage existing commercial as well as in-house codes to enable true multidisciplinary optimization in the preliminary design stage of subsonic, transonic, supersonic and hypersonic aircraft. Once the structural analysis discipline is finalized and integrated completely into the MDAO process, other disciplines such as aerodynamics and flight controls will be integrated as well. Simple and efficient model tuning capabilities based on optimization problem are successfully integrated with the MDAO tool. More synchronized all phases of experimental testing (ground and flight), analytical model updating, high-fidelity simulations for model validation, and integrated design may result in reduction of uncertainties in the aeroservoelastic model and increase the flight safety.

Soil Fumigant Labels - Dimethyl Disulfide (DMDS)

EPA Pesticide Factsheets

Search by EPA registration number, product name, or company and follow the link to the Pesticide Product Labeling System (PPLS) for label details. Updated labels include new safety requirements for buffer zones and related measures.

Soil Fumigant Labels - Metam Sodium/Potassium

EPA Pesticide Factsheets

Search by EPA registration number, product name, or company; and follow the link to the Pesticide Product Label System (PPLS) for details. Updated labels include new safety requirements for buffer zones and related measures.

Automotive fuel economy program

DOT National Transportation Integrated Search

2002-09-01

The Automotive Fuel Economy Program Annual Update summarizes the fuel economy performance of the vehicle fleet and the activities of the National Highway Traffic Safety Administration (NHTSA) during 2001. Included in this report is a section summariz...

Automotive fuel economy program

DOT National Transportation Integrated Search

2003-09-01

The Automotive Fuel Economy Program Annual Update summarizes the fuel economy performance of the vehicle fleet and the activities of the National Highway Traffic Safety Administration (NHTSA) during 2002. Included in this report is a section summariz...

Automotive fuel economy program

DOT National Transportation Integrated Search

2005-01-01

The Automotive Fuel Economy Program Annual Update summarizes the fuel economy performance of the vehicle fleet during 2004, and the activities of the National Highway Traffic Safety Administration (NHTSA) to date, including a section summarizing curr...

49 CFR 384.228 - Examiner training and record checks.

Code of Federal Regulations, 2012 CFR

2012-10-01

... regulations, updates to administering the tests, and new safety related equipment on the vehicles. (g... criminal background check must include at least the following: (i) Any felony conviction within the last 10...

49 CFR 659.39 - Oversight agency reporting to the Federal Transit Administration.

Code of Federal Regulations, 2014 CFR

2014-10-01

... accidents, status of corrective actions, updates and modifications to rail transit agency program...-year safety review has been completed since the last annual report was submitted. (3) Program standard...

49 CFR 659.39 - Oversight agency reporting to the Federal Transit Administration.

Code of Federal Regulations, 2011 CFR

2011-10-01

... accidents, status of corrective actions, updates and modifications to rail transit agency program...-year safety review has been completed since the last annual report was submitted. (3) Program standard...

49 CFR 659.39 - Oversight agency reporting to the Federal Transit Administration.

Code of Federal Regulations, 2013 CFR

2013-10-01

... accidents, status of corrective actions, updates and modifications to rail transit agency program...-year safety review has been completed since the last annual report was submitted. (3) Program standard...

49 CFR 659.39 - Oversight agency reporting to the Federal Transit Administration.

Code of Federal Regulations, 2012 CFR

2012-10-01

... accidents, status of corrective actions, updates and modifications to rail transit agency program...-year safety review has been completed since the last annual report was submitted. (3) Program standard...

Transportation infrastructure : states' implementation of transportation management systems

DOT National Transportation Integrated Search

1997-01-13

This report focuses on the U.S. General Accounting Office's ISTEA update of the states' implementation of pavement management systems, bridges, highway safety, congestion management systems, public transportation, and intermodal management systems. A...

Radiation Exposure and Pregnancy

MedlinePlus

Fact Sheet Adopted: June 2010 Updated: June 2017 Health Physics Society Specialists in Radiation Safety Radiation Exposure and ... radiation and pregnancy can be found on the Health Physics Society " Ask the Experts" Web site. she should ...

Intelligent transportation systems benefits, costs, and lessons learned : 2014 update report.

DOT National Transportation Integrated Search

2014-06-01

Intelligent transportation systems (ITS) provide a proven set of strategies for advancing transportation safety, mobility, and environmental sustainability by integrating communication and information technology applications into the management and o...

76 FR 52667 - International Conference on Harmonisation; Guidance on E2F Development Safety Update Report...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-23

... Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug...

New Method for Updating Mean Time Between Failure for ISS Orbital Replaceable Units Consultation Report

NASA Technical Reports Server (NTRS)

Parsons, Vickie S.

2009-01-01

A request to conduct a peer review of the International Space Station (ISS) proposal to use Bayesian methodology for updating Mean Time Between Failure (MTBF) for ISS Orbital Replaceable Units (ORU) was submitted to the NASA Engineering and Safety Center (NESC) on September 20, 2005. The results were requested by October 20, 2005 in order to be available during the process of reworking the current ISS flight manifest. The results are included in this report.

Aligning institutional priorities: engaging house staff in a quality improvement and safety initiative to fulfill Clinical Learning Environment Review objectives and electronic medical record Meaningful Use requirements.

PubMed

Flanagan, Meghan R; Foster, Carolyn C; Schleyer, Anneliese; Peterson, Gene N; Mandell, Samuel P; Rudd, Kristina E; Joyner, Byron D; Payne, Thomas H

2016-02-01

House staff quality improvement projects are often not aligned with training institution priorities. House staff are the primary users of inpatient problem lists in academic medical centers, and list maintenance has significant patient safety and financial implications. Improvement of the problem list is an important objective for hospitals with electronic health records under the Meaningful Use program. House staff surveys were used to create an electronic problem list manager (PLM) tool enabling efficient problem list updating. Number of new problems added and house staff perceptions of the problem list were compared before and after PLM intervention. The PLM was used by 654 house staff after release. Surveys demonstrated increased problem list updating (P = .002; response rate 47%). Mean new problems added per day increased from 64 pre-PLM to 125 post-PLM (P < .001). This innovative project serves as a model for successful engagement of house staff in institutional quality and safety initiatives with tangible institutional benefits. Copyright © 2016 Elsevier Inc. All rights reserved.

An update on anesthetics and impact on the brain.

PubMed

Fodale, Vincenzo; Tripodi, Vincenzo F; Penna, Olivia; Famà, Fausto; Squadrito, Francesco; Mondello, Epifanio; David, Antonio

2017-09-01

While anesthetics are indispensable clinical tools and generally considered safe and effective, a growing concern over the potential neurotoxicity of anesthesia or specific anesthetic agents has called into question the safety of general anesthetics, especially when administered at extremes of age. Areas covered: This article reviews and updates research findings on the safety of anesthesia and anesthetics in terms of long-term neurotoxicity, with particular focus on postoperative cognitive dysfunctions, Alzheimer's disease and dementias, developing brain, post-operative depression and autism spectrum disorder. Expert opinion: Exposure to general anesthetics is potentially harmful to the human brain, and the consequent long-term cognitive deficits should be classified as an iatrogenic pathology, and considered a public health problem. The fact that in laboratory and clinical research only certain anesthetic agents and techniques, but not others, appear to be involved, raises the problem on what is the safest and the least safe anesthetic to maximize anesthesia efficiency, avoid occurrence of adverse events, and ensure patient safety. New trends in research are moving toward the theory that neuroinflammation could be the hallmark of, or could have a pivotal role in, several neurological disorders.

Technical Review Report for the Model 9978-96 Package Safety Analysis Report for Packaging (S-SARP-G-00002, Revision 1, March 2009)

DOE Office of Scientific and Technical Information (OSTI.GOV)

West, M

2009-03-06

This Technical Review Report (TRR) documents the review, performed by Lawrence Livermore National Laboratory (LLNL) Staff, at the request of the Department of Energy (DOE), on the 'Safety Analysis Report for Packaging (SARP), Model 9978 B(M)F-96', Revision 1, March 2009 (S-SARP-G-00002). The Model 9978 Package complies with 10 CFR 71, and with 'Regulations for the Safe Transport of Radioactive Material-1996 Edition (As Amended, 2000)-Safety Requirements', International Atomic Energy Agency (IAEA) Safety Standards Series No. TS-R-1. The Model 9978 Packaging is designed, analyzed, fabricated, and tested in accordance with Section III of the American Society of Mechanical Engineers Boiler and Pressuremore » Vessel Code (ASME B&PVC). The review presented in this TRR was performed using the methods outlined in Revision 3 of the DOE's 'Packaging Review Guide (PRG) for Reviewing Safety Analysis Reports for Packages'. The format of the SARP follows that specified in Revision 2 of the Nuclear Regulatory Commission's Regulatory Guide 7.9, i.e., 'Standard Format and Content of Part 71 Applications for Approval of Packages for Radioactive Material'. Although the two documents are similar in their content, they are not identical. Formatting differences have been noted in this TRR, where appropriate. The Model 9978 Packaging is a single containment package, using a 5-inch containment vessel (5CV). It uses a nominal 35-gallon drum package design. In comparison, the Model 9977 Packaging uses a 6-inch containment vessel (6CV). The Model 9977 and Model 9978 Packagings were developed concurrently, and they were referred to as the General Purpose Fissile Material Package, Version 1 (GPFP). Both packagings use General Plastics FR-3716 polyurethane foam as insulation and as impact limiters. The 5CV is used as the Primary Containment Vessel (PCV) in the Model 9975-96 Packaging. The Model 9975-96 Packaging also has the 6CV as its Secondary Containment Vessel (SCV). In comparison, the Model 9975 Packagings use Celotex{trademark} for insulation and as impact limiters. To provide a historical perspective, it is noted that the Model 9975-96 Packaging is a 35-gallon drum package design that has evolved from a family of packages designed by DOE contractors at the Savannah River Site. Earlier package designs, i.e., the Model 9965, the Model 9966, the Model 9967, and the Model 9968 Packagings, were originally designed and certified in the early 1980s. In the 1990s, updated package designs that incorporated design features consistent with the then-newer safety requirements were proposed. The updated package designs at the time were the Model 9972, the Model 9973, the Model 9974, and the Model 9975 Packagings, respectively. The Model 9975 Package was certified by the Packaging Certification Program, under the Office of Safety Management and Operations. The Model 9978 Package has six Content Envelopes: C.1 ({sup 238}Pu Heat Sources), C.2 ( Pu/U Metals), C.3 (Pu/U Oxides, Reserved), C.4 (U Metal or Alloy), C.5 (U Compounds), and C.6 (Samples and Sources). Per 10 CFR 71.59 (Code of Federal Regulations), the value of N is 50 for the Model 9978 Package leading to a Criticality Safety Index (CSI) of 1.0. The Transport Index (TI), based on dose rate, is calculated to be a maximum of 4.1.« less

Special report. Revising your fire safety plans.

PubMed

1993-12-01

Every hospital has a fire safety plan, although some fail to update their plans when circumstances change, such as when the facility is refurbished or new fire protection equipment is added, or when new wings bring in additional patients and staff. Others may fail to develop new education programs to heighten staff awareness of what is expected of them during a fire and to train employees to meet those expectations. In this report, we'll examine the new fire safety plans at two Massachusetts hospitals and the revisions they made to address these issues. We'll offer suggestions for effectively evaluating and revising your own fire safety plans.

Safety of probiotics and synbiotics in children under 18 years of age.

PubMed

van den Nieuwboer, M; Brummer, R J; Guarner, F; Morelli, L; Cabana, M; Claassen, E

2015-01-01

This study aimed to systematically evaluate safety of probiotics and synbiotics in children ageing 0-18 years. This study is the third and final part in a safety trilogy and an update is provided using the most recent available clinical data (2008-2013) by means of the Common Terminology Clinical Adverse Events (CTCAE version 4.0) classification. Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. Analysis of 74 clinical studies indicated that probiotic and/or synbiotic administration in children is safe with regard to the specific evaluated strains, dosages and duration. The population of children include healthy, immune compromised and obese subjects, as well as subjects with intestinal disorders, infections and inflammatory disorders. This study revealed no major safety concerns, as the adverse events (AEs) were unrelated, or not suspected to be related, to the probiotic or synbiotic product. In general the study products were well tolerated. Overall, AEs occurred more frequent in the control arm compared to children receiving probiotics and/or synbiotics. Furthermore, the results indicate inadequate reporting and classification of AEs in the majority of the studies. In addition, generalizability of conclusions are greatly limited by the inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes.

Probiotic and synbiotic safety in infants under two years of age.

PubMed

van den Nieuwboer, M; Claassen, E; Morelli, L; Guarner, F; Brummer, R J

2014-03-01

In this study, we systematically evaluated safety aspects in clinical trials with probiotics and synbiotics in young infants (0-2 years of age). This study is an update of earlier reports and covers the recent literature from 2008-2013. The safety evaluation is performed along the Common Terminology Clinical Adverse Events (CTCAE) version 4.0 scale, hereby also providing guidance for future studies. Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. The results show a deficiency in the precise reporting and classification of adverse events in most studies. Analysis of 57 clinical trials with probiotics and synbiotics in combination with eight follow-up studies indicate that probiotic administration to infants between 0 and 24 months is safe with regard to the evaluated strains in infants with a particular health status or susceptibility. Most adverse events and serious adverse events were considered unrelated to the study product, and there were no major safety concerns. Almost all studies concluded that none of the adverse effects were related to the study product; the study products are generally well tolerated. Finally, inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes, greatly limit the generalizability of conclusions and argue convincingly for obligatory and standardised behaviour on adverse events (CTCAE) reporting in 'food' studies.

75 FR 13 - Alternate Fracture Toughness Requirements for Protection Against Pressurized Thermal Shock Events

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-04

...The Nuclear Regulatory Commission (NRC) is amending its regulations to provide alternate fracture toughness requirements for protection against pressurized thermal shock (PTS) events for pressurized water reactor (PWR) pressure vessels. This final rule provides alternate PTS requirements based on updated analysis methods. This action is desirable because the existing requirements are based on unnecessarily conservative probabilistic fracture mechanics analyses. This action reduces regulatory burden for those PWR licensees who expect to exceed the existing requirements before the expiration of their licenses, while maintaining adequate safety, and may choose to comply with the final rule as an alternative to complying with the existing requirements.

Covariance Data File Formats for Whisper-1.0 & Whisper-1.1

DOE Office of Scientific and Technical Information (OSTI.GOV)

Brown, Forrest B.; Rising, Michael Evan

2017-01-09

Whisper is a statistical analysis package developed in 2014 to support nuclear criticality safety (NCS) validation. It uses the sensitivity profile data for an application as computed by MCNP6 along with covariance files for the nuclear data to determine a baseline upper-subcritical-limit (USL) for the application. Whisper version 1.0 was first developed and used at LANL in 2014. During 2015-2016, Whisper was updated to version 1.1 and is to be included with the upcoming release of MCNP6.2. This report describes the file formats used for the covariance data in both Whisper-1.0 and Whisper-1.1.

Continuous quality improvement using intelligent infusion pump data analysis.

PubMed

Breland, Burnis D

2010-09-01

The use of continuous quality-improvement (CQI) processes in the implementation of intelligent infusion pumps in a community teaching hospital is described. After the decision was made to implement intelligent i.v. infusion pumps in a 413-bed, community teaching hospital, drug libraries for use in the safety software had to be created. Before drug libraries could be created, it was necessary to determine the epidemiology of medication use in various clinical care areas. Standardization of medication administration was performed through the CQI process, using practical knowledge of clinicians at the bedside and evidence-based drug safety parameters in the scientific literature. Post-implementation, CQI allowed refinement of clinically important safety limits while minimizing inappropriate, meaningless soft limit alerts on a few select agents. Assigning individual clinical care areas (CCAs) to individual patient care units facilitated customization of drug libraries and identification of specific CCA compliance concerns. Between June 2007 and June 2008, there were seven library updates. These involved drug additions and deletions, customization of individual CCAs, and alterations of limits. Overall compliance with safety software use rose over time, from 33% in November 2006 to over 98% in December 2009. Many potentially clinically significant dosing errors were intercepted by the safety software, prompting edits by end users. Only 4-6% of soft limit alerts resulted in edits. Compliance rates for use of infusion pump safety software varied among CCAs over time. Education, auditing, and refinement of drug libraries led to improved compliance in most CCAs.

Soil Fumigant Labels - Methyl Bromide

EPA Pesticide Factsheets

Search soil fumigant pesticide labels by EPA registration number, product name, or company, and follow the link to The Pesticide Product Label System (PPLS) for details. Updated labels include new safety requirements for buffer zones and related measures.

Soil Fumigant Labels - Chloropicrin

EPA Pesticide Factsheets

Search by EPA registration number, product name, or company name, and follow the link to the Pesticide Product Label System (PPLS) for details on each fumigant. Updated labels include new safety requirements for buffer zones and related measures.

Automotive fuel economy program

DOT National Transportation Integrated Search

2004-11-01

The Automotive Fuel Economy Program Annual Update summarizes the fuel economy performance of the vehicle fleet during 2003, and the activities of the National Highway Traffic Safety Administration (NHTSA) to date. Included in this report is a section...

49 CFR 384.228 - Examiner training and record checks.

Code of Federal Regulations, 2013 CFR

2013-10-01

... regulations, updates to administering the tests, and new safety related equipment on the vehicles. (g... background check must include at least the following: (i) Any felony conviction within the last 10 years; or...

49 CFR 384.228 - Examiner training and record checks.

Code of Federal Regulations, 2014 CFR

2014-10-01

... regulations, updates to administering the tests, and new safety related equipment on the vehicles. (g... background check must include at least the following: (i) Any felony conviction within the last 10 years; or...

76 FR 62817 - National Offshore Safety Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-11

... Joint Investigation Team for DEEPWATER HORIZON drilling rig explosion and sinking. (9) Update from the... Advisory Committee>NOSAC and then use the event key. The meeting will be recorded by a court reporter. A...

Prenatal Genetic Testing Chart

MedlinePlus

... www.acog.org/Patients/FAQs/Prenatal-Genetic-Diagnostic-Tests › › Resources & Publications Committee Opinions Practice Bulletins Patient Education Green Journal Clinical Updates Practice Management Coding Health Info Technology Professional Liability Managing Your Practice Patient Safety & Quality ...

Traffic incident management in construction and maintenance work zones.

DOT National Transportation Integrated Search

2009-01-01

In 2004, the Federal Highway Administration published updated rules governing work zone safety and mobility; all highway construction and maintenance projects using federal-aid highway funds are required to develop transportation management plans (TM...

To Your Health: NLM update transcript - Gun safety strategies

MedlinePlus

... elements that range from enforcing prohibited gun purchase laws to better crime detection, suggests a sweeping viewpoint ... Association . The authors, who are attorneys on the law faculties of Georgetown and Stanford Universities, suggest the ...

A real-time robot arm collision avoidance system

NASA Technical Reports Server (NTRS)

Shaffer, Clifford A.; Herb, Gregory M.

1992-01-01

A data structure and update algorithm are presented for a prototype real-time collision avoidance safety system simulating a multirobot workspace. The data structure is a variant of the octree, which serves as a spatial index. An octree recursively decomposes 3D space into eight equal cubic octants until each octant meets some decomposition criteria. The N-objects octree, which indexes a collection of 3D primitive solids is used. These primitives make up the two (seven-degrees-of-freedom) robot arms and workspace modeled by the system. As robot arms move, the octree is updated to reflect their changed positions. During most update cycles, any given primitive does not change which octree nodes it is in. Thus, modification to the octree is rarely required. Cycle time for interpreting current arm joint angles, updating the octree to reflect new positions, and detecting/reporting imminent collisions averages 30 ms on an Intel 80386 processor running at 20 MHz.

Review of AIDS development. [airborne computers for reliability engineering

NASA Technical Reports Server (NTRS)

Vermeulen, H. C.; Danielsson, S. G.

1981-01-01

The operation and implementation of the aircraft integrated data system AIDS are described. The system is described as an engineering tool with strong emphasis on analysis of recorded information. The AIDS is primarily directed to the monitoring of parameters related to: the safety of the flight; the performance of the aircraft; the performance of the flight guidance system; and the performance and condition of the engines. The system provide short term trend analysis on a trend chart that is updated by the flight engineer on every flight that lasts more than 4 flight hours. Engine data prints are automatically presented during take-off and in the case of limit excedance, e.g., the print shows an automatically reported impending hotstarts on engine nr. 1. Other significant features are reported.

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016.

PubMed

Bikson, Marom; Grossman, Pnina; Thomas, Chris; Zannou, Adantchede Louis; Jiang, Jimmy; Adnan, Tatheer; Mourdoukoutas, Antonios P; Kronberg, Greg; Truong, Dennis; Boggio, Paulo; Brunoni, André R; Charvet, Leigh; Fregni, Felipe; Fritsch, Brita; Gillick, Bernadette; Hamilton, Roy H; Hampstead, Benjamin M; Jankord, Ryan; Kirton, Adam; Knotkova, Helena; Liebetanz, David; Liu, Anli; Loo, Colleen; Nitsche, Michael A; Reis, Janine; Richardson, Jessica D; Rotenberg, Alexander; Turkeltaub, Peter E; Woods, Adam J

2016-01-01

This review updates and consolidates evidence on the safety of transcranial Direct Current Stimulation (tDCS). Safety is here operationally defined by, and limited to, the absence of evidence for a Serious Adverse Effect, the criteria for which are rigorously defined. This review adopts an evidence-based approach, based on an aggregation of experience from human trials, taking care not to confuse speculation on potential hazards or lack of data to refute such speculation with evidence for risk. Safety data from animal tests for tissue damage are reviewed with systematic consideration of translation to humans. Arbitrary safety considerations are avoided. Computational models are used to relate dose to brain exposure in humans and animals. We review relevant dose-response curves and dose metrics (e.g. current, duration, current density, charge, charge density) for meaningful safety standards. Special consideration is given to theoretically vulnerable populations including children and the elderly, subjects with mood disorders, epilepsy, stroke, implants, and home users. Evidence from relevant animal models indicates that brain injury by Direct Current Stimulation (DCS) occurs at predicted brain current densities (6.3-13 A/m(2)) that are over an order of magnitude above those produced by conventional tDCS. To date, the use of conventional tDCS protocols in human trials (≤40 min, ≤4 milliamperes, ≤7.2 Coulombs) has not produced any reports of a Serious Adverse Effect or irreversible injury across over 33,200 sessions and 1000 subjects with repeated sessions. This includes a wide variety of subjects, including persons from potentially vulnerable populations. Copyright © 2016 Elsevier Inc. All rights reserved.

Safety of transcranial Direct Current Stimulation: Evidence Based Update 2016

PubMed Central

Bikson, Marom; Grossman, Pnina; Thomas, Chris; Zannou, Adantchede Louis; Jiang, Jimmy; Adnan, Tatheer; Mourdoukoutas, Antonios P; Kronberg, Greg; Truong, Dennis; Boggio, Paulo; Brunoni, André R.; Charvet, Leigh; Fregni, Felipe; Fritsch, Brita; Gillick, Bernadette; Hamilton, Roy H.; Hampstead, Benjamin M.; Jankord, Ryan; Kirton, Adam; Knotkova, Helena; Liebetanz, David; Liu, Anli; Loo, Colleen; Nitsche, Michael A.; Reis, Janine; Richardson, Jessica D.; Rotenberg, Alexander; Turkeltaub, Peter E.; Woods, Adam J.

2016-01-01

This review updates and consolidates evidence on the safety of transcranial Direct Current Stimulation (tDCS). Safety is here operationally defined by, and limited to, the absence of evidence for a Serious Adverse Effect, the criteria for which are rigorously defined. This review adopts an evidence-based approach, based on an aggregation of experience from human trials, taking care not to confuse speculation on potential hazards or lack of data to refute such speculation with evidence for risk. Safety data from animal tests for tissue damage are reviewed with systematic consideration of translation to humans. Arbitrary safety considerations are avoided. Computational models are used to relate dose to brain exposure in humans and animals. We review relevant dose-response curves and dose metrics (e.g. current, duration, current density, charge, charge density) for meaningful safety standards. Special consideration is given to theoretically vulnerable populations including children and the elderly, subjects with mood disorders, epilepsy, stroke, implants, and home users. Evidence from relevant animal models indicates that brain injury by Direct Current Stimulation (DCS) occurs at predicted brain current densities (6.3–13 A/m2) that are over an order of magnitude above those produced by conventional tDCS. To date, the use of conventional tDCS protocols in human trials (≤40 min, ≤4 mA, ≤7.2 Coulombs) has not produced any reports of a Serious Adverse Effect or irreversible injury across over 33,200 sessions and 1,000 subjects with repeated sessions. This includes a wide variety of subjects, including persons from potentially vulnerable populations. PMID:27372845

New risk metrics and mathematical tools for risk analysis: Current and future challenges

DOE Office of Scientific and Technical Information (OSTI.GOV)

Skandamis, Panagiotis N., E-mail: pskan@aua.gr; Andritsos, Nikolaos, E-mail: pskan@aua.gr; Psomas, Antonios, E-mail: pskan@aua.gr

The current status of the food safety supply world wide, has led Food and Agriculture Organization (FAO) and World Health Organization (WHO) to establishing Risk Analysis as the single framework for building food safety control programs. A series of guidelines and reports that detail out the various steps in Risk Analysis, namely Risk Management, Risk Assessment and Risk Communication is available. The Risk Analysis approach enables integration between operational food management systems, such as Hazard Analysis Critical Control Points, public health and governmental decisions. To do that, a series of new Risk Metrics has been established as follows: i) themore » Appropriate Level of Protection (ALOP), which indicates the maximum numbers of illnesses in a population per annum, defined by quantitative risk assessments, and used to establish; ii) Food Safety Objective (FSO), which sets the maximum frequency and/or concentration of a hazard in a food at the time of consumption that provides or contributes to the ALOP. Given that ALOP is rather a metric of the public health tolerable burden (it addresses the total ‘failure’ that may be handled at a national level), it is difficult to be interpreted into control measures applied at the manufacturing level. Thus, a series of specific objectives and criteria for performance of individual processes and products have been established, all of them assisting in the achievement of FSO and hence, ALOP. In order to achieve FSO, tools quantifying the effect of processes and intrinsic properties of foods on survival and growth of pathogens are essential. In this context, predictive microbiology and risk assessment have offered an important assistance to Food Safety Management. Predictive modelling is the basis of exposure assessment and the development of stochastic and kinetic models, which are also available in the form of Web-based applications, e.g., COMBASE and Microbial Responses Viewer), or introduced into user-friendly softwares, (e.g., Seafood Spoilage Predictor) have evolved the use of information systems in the food safety management. Such tools are updateable with new food-pathogen specific models containing cardinal parameters and multiple dependent variables, including plate counts, concentration of metabolic products, or even expression levels of certain genes. Then, these tools may further serve as decision-support tools which may assist in product logistics, based on their scientifically-based and “momentary” expressed spoilage and safety level.« less

New risk metrics and mathematical tools for risk analysis: Current and future challenges

NASA Astrophysics Data System (ADS)

Skandamis, Panagiotis N.; Andritsos, Nikolaos; Psomas, Antonios; Paramythiotis, Spyridon

2015-01-01

The current status of the food safety supply world wide, has led Food and Agriculture Organization (FAO) and World Health Organization (WHO) to establishing Risk Analysis as the single framework for building food safety control programs. A series of guidelines and reports that detail out the various steps in Risk Analysis, namely Risk Management, Risk Assessment and Risk Communication is available. The Risk Analysis approach enables integration between operational food management systems, such as Hazard Analysis Critical Control Points, public health and governmental decisions. To do that, a series of new Risk Metrics has been established as follows: i) the Appropriate Level of Protection (ALOP), which indicates the maximum numbers of illnesses in a population per annum, defined by quantitative risk assessments, and used to establish; ii) Food Safety Objective (FSO), which sets the maximum frequency and/or concentration of a hazard in a food at the time of consumption that provides or contributes to the ALOP. Given that ALOP is rather a metric of the public health tolerable burden (it addresses the total `failure' that may be handled at a national level), it is difficult to be interpreted into control measures applied at the manufacturing level. Thus, a series of specific objectives and criteria for performance of individual processes and products have been established, all of them assisting in the achievement of FSO and hence, ALOP. In order to achieve FSO, tools quantifying the effect of processes and intrinsic properties of foods on survival and growth of pathogens are essential. In this context, predictive microbiology and risk assessment have offered an important assistance to Food Safety Management. Predictive modelling is the basis of exposure assessment and the development of stochastic and kinetic models, which are also available in the form of Web-based applications, e.g., COMBASE and Microbial Responses Viewer), or introduced into user-friendly softwares, (e.g., Seafood Spoilage Predictor) have evolved the use of information systems in the food safety management. Such tools are updateable with new food-pathogen specific models containing cardinal parameters and multiple dependent variables, including plate counts, concentration of metabolic products, or even expression levels of certain genes. Then, these tools may further serve as decision-support tools which may assist in product logistics, based on their scientifically-based and "momentary" expressed spoilage and safety level.

Clinician's guide to assessing and counseling older drivers, 3rd Edition.

DOT National Transportation Integrated Search

2015-01-01

The American Geriatrics Society (AGS) entered into a cooperative agreement with the U. S . : Department of Transportations National Highway Traffic Safety Administration (NHTSA) to : update and expand the Physicians Guide to Assessing and Couns...

U.S. Coast Guard, Office of Boating Safety

MedlinePlus

... COAST GUARD ISSUES FINALE RULE – UPDATE OF OUTBOARD ENGINE WEIGHT TEST REQUIREMENTS FY18 National Nonprofit Organization Funding ... operator, passenger, or concerned individual, can make a difference. Manufacturers Is your boat safe? You can check ...

Intelligent transportation systems benefits, costs, and lessons learned : 2005 update

DOT National Transportation Integrated Search

2005-05-01

Intelligent Transportation Systems (ITS) technologies offer a clear opportunity to improve transportation safety, relieve congestion, and enhance productivity. This report is a continuation of a series of reports providing a synthesis of the informat...

Update from C3RS lessons learned team : four demonstration pilots.

DOT National Transportation Integrated Search

2014-07-01

The Federal Railroad Administration (FRA) believes that, in addition to process and technology innovations, human-factors-based solutions can significantly contribute to improving safety in the railroad industry. To test this assumption, FRA implemen...

Report: CSB's Fiscal Year 2014 Management Challenges

EPA Pesticide Factsheets

June 9, 2014. The Office of Inspector General is beginning work to update the fiscal year 2014 list of areas we consider to be the key management challenges confronting the U.S. Chemical Safety and Hazard Investigation Board.

Facility effluent monitoring plan for the plutonium uranium extraction facility

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wiegand, D.L.

A facility effluent monitoring plan is required by the US Department of Energy in DOE Order 5400.1 for any operations that involve hazardous materials and radioactive substances that could impact employee or public safety or the environment. This document is prepared using the specific guidelines identified in A Guide for Preparing Hanford Site Facility Effluent Monitoring Plans, WHC-EP-0438-01. This facility effluent monitoring plan assesses effluent monitoring systems and evaluates whether they are adequate to ensure the public health and safety as specified in applicable federal, state, and local requirements. This facility effluent monitoring plan shall ensure long-range integrity of themore » effluent monitoring systems by requiring an update whenever a new process or operation introduces new hazardous materials or significant radioactive materials. This document must be reviewed annually even if there are no operational changes, and it must be updated at a minimum of every three years.« less

Qualitative Future Safety Risk Identification an Update

NASA Technical Reports Server (NTRS)

Barr, Lawrence C.

2017-01-01

The purpose of this report is to document the results of a high-level qualitative study that was conducted to identify future aviation safety risks and to assess the potential impacts to the National Airspace System (NAS) of NASA Aviation Safety research on these risks. Multiple external sources (for example, the National Transportation Safety Board, the Flight Safety Foundation, the National Research Council, and the Joint Planning and Development Office) were used to develop a compilation of future safety issues risks, also referred to as future tall poles. The primary criterion used to identify the most critical future safety risk issues was that the issue must be cited in several of these sources as a safety area of concern. The tall poles in future safety risk, in no particular order of importance, are as follows: Runway Safety, Loss of Control In Flight, Icing Ice Detection, Loss of Separation, Near Midair Collision Human Fatigue, Increasing Complexity and Reliance on Automation, Vulnerability Discovery, Data Sharing and Dissemination, and Enhanced Survivability in the Event of an Accident.

Child Labor: Labor Can Strengthen Its Efforts To Protect Children Who Work. Report to the Chairman, Subcommittee on Labor, Health and Human Services, and Education, Committee on Appropriations, U.S. Senate.

ERIC Educational Resources Information Center

General Accounting Office, Washington, DC.

Occupational safety and health data and labor statistics were evaluated in order to update a 1991 report on child labor. Data were from the Bureau of Labor Statistics; Department of Health and Human Services; National Institutes for Occupational Safety and Health (NIOSH); the Department of Labor's (DOL's) investigations database and individual…

Evolution and Implementation of the NASA Robotic Conjunction Assessment Risk Analysis Concept of Operations

NASA Technical Reports Server (NTRS)

Newman, Lauri K.; Frigm, Ryan C.; Duncan, Matthew G.; Hejduk, Matthew D.

2014-01-01

Reacting to potential on-orbit collision risk in an operational environment requires timely and accurate communication and exchange of data, information, and analysis to ensure informed decision-making for safety of flight and responsible use of the shared space environment. To accomplish this mission, it is imperative that all stakeholders effectively manage resources: devoting necessary and potentially intensive resource commitment to responding to high-risk conjunction events and preventing unnecessary expenditure of resources on events of low collision risk. After 10 years of operational experience, the NASA Robotic Conjunction Assessment Risk Analysis (CARA) is modifying its Concept of Operations (CONOPS) to ensure this alignment of collision risk and resource management. This evolution manifests itself in the approach to characterizing, reporting, and refining of collision risk. Implementation of this updated CONOPS is expected to have a demonstrated improvement on the efficacy of JSpOC, CARA, and owner/operator resources.

Selected aspects of prior and likelihood information for a Bayesian classifier in a road safety analysis.

PubMed

Nowakowska, Marzena

2017-04-01

The development of the Bayesian logistic regression model classifying the road accident severity is discussed. The already exploited informative priors (method of moments, maximum likelihood estimation, and two-stage Bayesian updating), along with the original idea of a Boot prior proposal, are investigated when no expert opinion has been available. In addition, two possible approaches to updating the priors, in the form of unbalanced and balanced training data sets, are presented. The obtained logistic Bayesian models are assessed on the basis of a deviance information criterion (DIC), highest probability density (HPD) intervals, and coefficients of variation estimated for the model parameters. The verification of the model accuracy has been based on sensitivity, specificity and the harmonic mean of sensitivity and specificity, all calculated from a test data set. The models obtained from the balanced training data set have a better classification quality than the ones obtained from the unbalanced training data set. The two-stage Bayesian updating prior model and the Boot prior model, both identified with the use of the balanced training data set, outperform the non-informative, method of moments, and maximum likelihood estimation prior models. It is important to note that one should be careful when interpreting the parameters since different priors can lead to different models. Copyright © 2017 Elsevier Ltd. All rights reserved.

Efficacy and Safety of Atomoxetine in the Treatment of Children and Adolescents with Attention Deficit Hyperactivity Disorder

PubMed Central

Kohn, Michael R.; Tsang, Tracey W.; Clarke, Simon D.

2012-01-01

Several non-stimulant medications have been used in the treatment of attention deficit hyperactivity disorder (ADHD). Atomoxetine, was introduced in 2002. The safety and efficacy of atomoxetine in the treatment of ADHD for children, adolescents, and adults has been evaluated in over 4000 patients in randomized controlled studies and double blinded studies as well as in recent large longitudinal studies. This paper provides an updated summary of the literature on atomoxetine, particularly in relation to findings on the short- and long-term safety of atomoxetine in children and adolescents arising from recent large longitudinal cohort studies. Information is presented about the efficacy, safety, and tolerability of this medication. PMID:23641171

77 FR 24941 - Vantage Wind Energy LLC; Order Accepting Updated Market Power Analysis and Providing Direction on...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-26

.... 1. In this order, the Commission accepts an updated market power analysis filed by Vantage Wind.... Background 3. On December 20, 2010, Vantage Wind filed an updated market power analysis in compliance with... power analysis filed by Puget Sound Energy, Inc. (Puget).\\4\\ \\3\\ See Vantage Wind Energy LLC, Docket No...

Technical Review Report for the Mound 1KW Package Safety Analysis Report for Packaging Waiver for the Use of Modified Primary Containment Vessel (PCV)

DOE Office of Scientific and Technical Information (OSTI.GOV)

West, M; Hafner, R

2008-05-05

This Technical Review Report (TRR) documents the review, performed by the Lawrence Livermore National Laboratory (LLNL) staff, at the request of the U.S. Department of Energy (DOE), on the Waiver for the Use of Modified Primary Containment Vessels (PCV). The waiver is to be used to support a limited number of shipments of fuel for the Multi-Mission Radioisotope Thermoelectric Generator (MMRTG) Project in support of the National Aeronautics and Space Administration's (NASA's) Mars Science Laboratory (MSL) mission. Under the waiver, an inventory of existing national security PCVs will be converted to standard PCVs. Both types of PCVs are currently approvedmore » for use by the Office of Nuclear Energy. LLNL has previously reviewed the national security PCVs under Mound 1KW Package Safety Analysis Report for Packaging, Addendum No. 1, Revision c, dated June 2007 (Addendum 1). The safety analysis of the package is documented in the Safety Analysis Report for Packaging (SARP) for the Mound 1KW Package (i.e., the Mound 1KW SARP, or the SARP) where the standard PCVs have been reviewed by LLNL. The Mound 1KW Package is certified by DOE Certificate of Compliance (CoC) number USA/9516/B(U)F-85 for the transportation of Type B quantities of plutonium heat source material. The waiver requests an exemption, claiming safety equivalent to the requirements specified in 10 CFR 71.12, Specific Exemptions, and will lead to a letter amendment to the CoC. Under the waiver, the Office of Radioisotope Power Systems, NE-34, is seeking an exemption from 10 CFR 71.19(d)(1), Previously Approved Package,[5] which states: '(d) NRC will approve modifications to the design and authorized contents of a Type B package, or a fissile material package, previously approved by NRC, provided--(1) The modifications of a Type B package are not significant with respect to the design, operating characteristics, or safe performance of the containment system, when the package is subjected to the tests specified in {section}71.71 and 71.73.' The LLNL staff had previously reviewed a request from Idaho National Laboratory (INL) to reconfigure national security PCVs to standard PCVs. With a nominal 50% reduction in both the height and the volume, the LLNL staff initially deemed the modifications to be significant, which would not be allowed under the provisions of 10 CFR 71.19(d)(1)--see above. As a follow-up, the DOE requested additional clarification from the Nuclear Regulatory Commission (NRC). The NRC concluded that the reconfiguration would be a new fabrication, and that an exemption to the regulations would be required to allow its use, as per the requirements specified in 10 CFR 71.19(c)(1), Previously Approved Package: '(c) A Type B(U) package, a Type B(M) package, or a fissile material package previously approved by the NRC with the designation '-85' in the identification number of the NRC CoC, may be used under the general license of {section}71.17 with the following additional conditions: (1) Fabrication of the package must be satisfactorily completed by December 31, 2006, as demonstrated by application of its model number in accordance with 71.85(c).' Although the preferred approach toward the resolution of this issue would be for the applicant to submit an updated SARP, the applicant has stated that the process of updating the Model Mound 1KW Package SARP is a work that is in progress, but that the updated SARP is not yet ready for submittal. The applicant has to provide a submittal, proving that the package meets the '-96' requirements of International Atomic Energy Agency (IAEA) Safety Standards Series No. TS-R-1, in order to fabricate approved packagings after December 31, 2006. The applicant has further stated that all other packaging features, as described in the currently approved Model Mound 1KW Package SARP, remain unchanged. This report documents the LLNL review of the waiver request. The specific review for each SARP Chapter is documented.« less

The Propulsive Small Expendable Deployer System (ProSEDS)

NASA Technical Reports Server (NTRS)

Lorenzini, Enrico C.; Cosmo, Mario L.; Estes, Robert D.; Sanmartin, Juan; Pelaez, Jesus; Ruiz, Manuel

2003-01-01

This Final Report covers the following main topics: 1) Brief Description of ProSEDS; 2) Mission Analysis; 3) Dynamics Reference Mission; 4) Dynamics Stability; 5) Deployment Control; 6) Updated System Performance; 7) Updated Mission Analysis; 8) Updated Dynamics Reference Mission; 9) Updated Deployment Control Profiles and Simulations; 10) Updated Reference Mission; 11) Evaluation of Power Delivered by the Tether; 12) Deployment Control Profile Ref. #78 and Simulations; 13) Kalman Filters for Mission Estimation; 14) Analysis/Estimation of Deployment Flight Data; 15) Comparison of ED Tethers and Electrical Thrusters; 16) Dynamics Analysis for Mission Starting at a Lower Altitude; 17) Deployment Performance at a Lower Altitude; 18) Satellite Orbit after a Tether Cut; 19) Deployment with Shorter Dyneema Tether Length; 20) Interactive Software for ED Tethers.

New highway accident location manual for Missouri.

DOT National Transportation Integrated Search

2013-12-01

The Missouri HAL manual is used to identify, analyze, and correct high crash locations, and has not been updated since : 1999. This new edition brings the manual up to date, while incorporating the methodology of the national Highway Safety : Manual ...

2003 status report on transit intelligent vehicle initiative studies

DOT National Transportation Integrated Search

2003-06-01

This 2003 Status Report provides an overview and updates on studies in the transit Intelligent Vehicle Initiative (IVI) area. IVI emphasizes the significant and continuing role of drivers in roadway safety. IVI is aimed at accelerating the developmen...

77 FR 58608 - Railroad Safety Advisory Committee (RSAC); Working Group Activity Update

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-21

... published on April 18, 2012 (77 FR 23159). Contact: Steve Clay, (202) 493-6259. Task 06-03--Medical... environmental, sanitary, and other working conditions in locomotive cabs affect the crew's health and the safe...

Health Topics: MedlinePlus

MedlinePlus

... Groups Seniors Women Health and Wellness Expand Section Disasters Fitness and Exercise Food and Nutrition Health System Personal Health Issues Safety Issues Sexual Health Issues Social/Family Issues Wellness and Lifestyle About MedlinePlus Site Map FAQs Customer Support Get email updates Subscribe ...

NASA GSFC Mechanical Engineering Latest Inputs for Verification Standards (GEVS) Updates

NASA Technical Reports Server (NTRS)

Kaufman, Daniel

2003-01-01

This viewgraph presentation provides information on quality control standards in mechanical engineering. The presentation addresses safety, structural loads, nonmetallic composite structural elements, bonded structural joints, externally induced shock, random vibration, acoustic tests, and mechanical function.

Notification: FY 2018 CSB Management Challenges and Internal Control Weaknesses

EPA Pesticide Factsheets

December 26, 2017. The OIG is beginning work to update for fiscal year 2018 its list of proposed key management challenges and internal control weaknesses confronting the U.S. Chemical Safety and Hazard Investigation Board (CSB).

77 FR 58557 - Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-21

..., will include NCEH/ATSDR Office of the Director updates: ATSDR Reorganization, Asthma, Lead and Healthy... activities at the National Institute for Occupational Safety and Health, U.S. Department of Energy, National...

Los Alamos Climatology 2016 Update

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bruggeman, David Alan

The Los Alamos National Laboratory (LANL or the Laboratory) operates a meteorology monitoring network to support LANL emergency response, engineering designs, environmental compliance, environmental assessments, safety evaluations, weather forecasting, environmental monitoring, research programs, and environmental restoration. Weather data has been collected in Los Alamos since 1910. Bowen (1990) provided climate statistics (temperature and precipitation) for the 1961– 1990 averaging period, and included other analyses (e.g., wind and relative humidity) based on the available station locations and time periods. This report provides an update to the 1990 publication Los Alamos Climatology (Bowen 1990).

NASA Accident Precursor Analysis Handbook, Version 1.0

NASA Technical Reports Server (NTRS)

Groen, Frank; Everett, Chris; Hall, Anthony; Insley, Scott

2011-01-01

Catastrophic accidents are usually preceded by precursory events that, although observable, are not recognized as harbingers of a tragedy until after the fact. In the nuclear industry, the Three Mile Island accident was preceded by at least two events portending the potential for severe consequences from an underappreciated causal mechanism. Anomalies whose failure mechanisms were integral to the losses of Space Transportation Systems (STS) Challenger and Columbia had been occurring within the STS fleet prior to those accidents. Both the Rogers Commission Report and the Columbia Accident Investigation Board report found that processes in place at the time did not respond to the prior anomalies in a way that shed light on their true risk implications. This includes the concern that, in the words of the NASA Aerospace Safety Advisory Panel (ASAP), "no process addresses the need to update a hazard analysis when anomalies occur" At a broader level, the ASAP noted in 2007 that NASA "could better gauge the likelihood of losses by developing leading indicators, rather than continue to depend on lagging indicators". These observations suggest a need to revalidate prior assumptions and conclusions of existing safety (and reliability) analyses, as well as to consider the potential for previously unrecognized accident scenarios, when unexpected or otherwise undesired behaviors of the system are observed. This need is also discussed in NASA's system safety handbook, which advocates a view of safety assurance as driving a program to take steps that are necessary to establish and maintain a valid and credible argument for the safety of its missions. It is the premise of this handbook that making cases for safety more experience-based allows NASA to be better informed about the safety performance of its systems, and will ultimately help it to manage safety in a more effective manner. The APA process described in this handbook provides a systematic means of analyzing candidate accident precursors by evaluating anomaly occurrences for their system safety implications and, through both analytical and deliberative methods used to project to other circumstances, identifying those that portend more serious consequences to come if effective corrective action is not taken. APA builds upon existing safety analysis processes currently in practice within NASA, leveraging their results to provide an improved understanding of overall system risk. As such, APA represents an important dimension of safety evaluation; as operational experience is acquired, precursor information is generated such that it can be fed back into system safety analyses to risk-inform safety improvements. Importantly, APA utilizes anomaly data to predict risk whereas standard reliability and PRA approaches utilize failure data which often is limited and rare.

Extraglottic airway devices: technology update.

PubMed

Sharma, Bimla; Sahai, Chand; Sood, Jayashree

2017-01-01

Extraglottic airway devices (EADs) have revolutionized the field of airway management. The invention of the laryngeal mask airway was a game changer, and since then, there have been several innovations to improve the EADs in design, functionality, safety and construction material. These have ranged from changes in the shape of the mask, number of cuffs and material used, like rubber, polyvinylchloride and latex. Phthalates, which were added to the construction material in order to increase device flexibility, were later omitted when this chemical was found to have serious adverse reproductive outcomes. The various designs brought out by numerous companies manufacturing EADs resulted in the addition of several devices to the airway market. These airway devices were put to use, many of them with inadequate or no evidence base regarding their efficacy and safety. To reduce the possibility of compromising the safety of the patient, the Difficult Airway Society (DAS) formed the Airway Device Evaluation Project Team (ADEPT) to strengthen the evidence base for airway equipment and vet the new extraglottic devices. A preuse careful analysis of the design and structure may help in better understanding of the functionality of a particular device. In the meantime, the search for the ideal EAD continues.

Study report recommendations for the next generation Range Safety System (RSS) Integrated Receiver/Decoder (IRD)

NASA Technical Reports Server (NTRS)

Crosby, Robert H.

1992-01-01

The Integrated Receiver/Decoder (IRD) currently used on the Space Shuttle was designed in the 1980 and prior time frame. Over the past 12 years, several parts have become obsolete or difficult to obtain. As directed by the Marshall Space Flight Center, a primary objective is to investigate updating the IRD design using the latest technology subsystems. To take advantage of experience with the current designs, an analysis of failures and a review of discrepancy reports, material review board actions, scrap, etc. are given. A recommended new design designated as the Advanced Receiver/Decoder (ARD) is presented. This design uses the latest technology components to simplify circuits, improve performance, reduce size and cost, and improve reliability. A self-test command is recommended that can improve and simplify operational procedures. Here, the new design is contrasted with the old. Possible simplification of the total Range Safety System is discussed, as is a single-step crypto technique that can improve and simplify operational procedures.

DEVELOPMENT OF HFE SECTIONS OF DG-1145.

DOE Office of Scientific and Technical Information (OSTI.GOV)

HIGGINS,J.C.; OHARA, J.M.; BONGARRA, J.

2007-03-26

For the licensing of the current fleet of commercial nuclear power plants (NPPs), the Nuclear Regulatory Commission (NRC) used two key documents, NUREG-0800 and Regulatory Guide (RG) 1.70. RG 1.70 provided guidance to applicants on the contents needed in their Safety Analysis Reports (SARs) submitted as part of their application to construct or operate an NPP. NUREG-0800, the NRC Standard Review Plan (SRP), provides guidance to the NRR staff reviewers on performing their safety reviews of these applications. As part of the preparation for a new wave of improved NPP designs the NRC is in the process of updating themore » SRP and is also developing a new RG designated as draft RG or DG-1145, ''Combined License Applications for Nuclear Power Plants (LWR Edition).'' This will eventually become RG 1.206 and will take the place of RG 1.70. This will provide guidance for combined license (COL) applicants, as well as for other 10CFR Part 52 variations that are permitted.« less

Recommendations for toxicological investigation of drug-impaired driving and motor vehicle fatalities.

PubMed

Logan, Barry K; Lowrie, Kayla J; Turri, Jennifer L; Yeakel, Jillian K; Limoges, Jennifer F; Miles, Amy K; Scarneo, Colleen E; Kerrigan, Sarah; Farrell, Laurel J

2013-10-01

This report describes the review and update of a set of minimum recommendations for the toxicological investigation of suspected alcohol and drug-impaired driving cases and motor vehicle fatalities involving drugs or alcohol. The recommendations have the goal of ensuring that a consistent set of data regarding the most frequently encountered drugs linked to driving impairment is collected for practical application in the investigation of these cases and to allow epidemiological monitoring and the development of evidence-based public policy on this important public safety issue. The recommendations are based on a survey of practices in US laboratories performing this kind of analysis, consideration of existing epidemiological crash and arrest data and practical considerations of widely available technology platforms in laboratories performing this work. The final recommendations were derived from a consensus meeting of experts recruited from survey respondents and the membership of the National Safety Council's Alcohol, Drug and Impairment Division (formerly known as the Committee on Alcohol and Other Drugs, CAOD).

Common problems in the elicitation and analysis of expert opinion affecting probabilistic safety assessments

DOE Office of Scientific and Technical Information (OSTI.GOV)

Meyer, M.A.; Booker, J.M.

1990-01-01

Expert opinion is frequently used in probabilistic safety assessment (PSA), particularly in estimating low probability events. In this paper, we discuss some of the common problems encountered in eliciting and analyzing expert opinion data and offer solutions or recommendations. The problems are: that experts are not naturally Bayesian. People fail to update their existing information to account for new information as it becomes available, as would be predicted by the Bayesian philosophy; that experts cannot be fully calibrated. To calibrate experts, the feedback from the known quantities must be immediate, frequent, and specific to the task; that experts are limitedmore » in the number of things that they can mentally juggle at a time to 7 {plus minus} 2; that data gatherers and analysts can introduce bias by unintentionally causing an altering of the expert's thinking or answers; that the level of detail the data, or granularity, can affect the analyses; and the conditioning effect poses difficulties in gathering and analyzing of the expert data. The data that the expert gives can be conditioned on a variety of factors that can affect the analysis and the interpretation of the results. 31 refs.« less

RSRM TP-H1148 Main Grain Propellant Crack Initiation Evaluation

NASA Technical Reports Server (NTRS)

Earnest, Todd E.

2005-01-01

Pressurized TP-HI 148 propellant fracture toughness testing was performed to assess the potential for initiation of visually undetectable cracks in the RSRM forward segment transition region during motor ignition. Two separate test specimens were used in this evaluation. Testing was performed in cold-gas and hot-fire environments, and under both static and dynamic pressurization conditions. Analysis of test results demonstrates safety factors against initiation of visually undetectable cracks in excess of 8.0. The Reusable Solid Rocket Motor (RSRM) forward segment is cast with PBAN propellant (TP-HI 148) to form T an 1 1-point star configuration that transitions to a tapered center perforated bore (see Figure 1). The geometry of the transition region between the fin valleys and the bore causes a localized area of high strain during horizontal storage. Updated analyses using worst-case mechanical properties at 40 F and improved modeling techniques indicated a slight reduction in safety margins over previous predictions. Although there is no history of strain induced cracks or flaws in the transition region propellant, a proactive test effort was initiated to better understand the implications of the new analysis, primarily the resistance of TP-H1148 propellant to crack initiation' during RSRM ignition.

A Probabilistic Approach to Model Update

NASA Technical Reports Server (NTRS)

Horta, Lucas G.; Reaves, Mercedes C.; Voracek, David F.

2001-01-01

Finite element models are often developed for load validation, structural certification, response predictions, and to study alternate design concepts. In rare occasions, models developed with a nominal set of parameters agree with experimental data without the need to update parameter values. Today, model updating is generally heuristic and often performed by a skilled analyst with in-depth understanding of the model assumptions. Parameter uncertainties play a key role in understanding the model update problem and therefore probabilistic analysis tools, developed for reliability and risk analysis, may be used to incorporate uncertainty in the analysis. In this work, probability analysis (PA) tools are used to aid the parameter update task using experimental data and some basic knowledge of potential error sources. Discussed here is the first application of PA tools to update parameters of a finite element model for a composite wing structure. Static deflection data at six locations are used to update five parameters. It is shown that while prediction of individual response values may not be matched identically, the system response is significantly improved with moderate changes in parameter values.

Transvaginal mesh in the media following the 2011 US food and drug administration public health notification update.

PubMed

Koo, Kevin; Gormley, E Ann

2017-02-01

Prompted by patients' changing perceptions of transvaginal mesh, this study examines how mesh has been reported in the news following the 2011 US Food and Drug Administration (FDA) updated notification about the use of mesh in the treatment of pelvic organ prolapse. Two national newspaper databases were queried for articles discussing transvaginal mesh published within 3 years of the FDA announcement. Content analysis included headline subjects, mesh-related complications, quoted sources, and the FDA recommendations. To determine whether more widely read sources publish higher quality reporting, a subgroup analysis was conducted based on newspaper circulation. Ninety-five articles met inclusion criteria. Mesh-related litigation was the most common headline subject (36 articles, 38%), and 54% of all articles referenced legal action. Fifty-seven articles (60%) cited at least one mesh-related complication. Only 18 articles (19%) quoted surgeons who use transvaginal mesh. For the FDA update, 40% of articles that first reported the announcement accurately specified that it applies to mesh for prolapse, not incontinence. This ambiguity persisted: half of all articles cited the warning, but only 23% distinguished between prolapse and incontinence. Higher newspaper circulation did not significantly improve the quality of reporting about the content or context of the FDA's recommendations. Despite frequent media coverage of transvaginal mesh and its complications since 2011, very few news sources that cited the FDA warning distinguished between prolapse and incontinence. Given prevalent reporting of mesh-related litigation, the findings raise concern about how patients perceive the safety and efficacy of transvaginal mesh, regardless of indication. Neurourol. Urodynam. 36:329-332, 2017. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

Pirfenidone, nintedanib and N-acetylcysteine for the treatment of idiopathic pulmonary fibrosis: A systematic review and meta-analysis.

PubMed

Rogliani, Paola; Calzetta, Luigino; Cavalli, Francesco; Matera, Maria Gabriella; Cazzola, Mario

2016-10-01

The prevalence of idiopathic pulmonary fibrosis (IPF) is increasing every year. Pirfenidone and nintedanib were approved for treatment of IPF in 2014, but they received only a conditional recommendation for use and, thus, to date no drugs are strongly recommended for IPF. The aim of this study was to assess the effectiveness and safety of the currently approved drugs for IPF and N-acetylcysteine (NAC), the most debated drug in the last update of guidelines for IPF treatment. RCTs in IPF were identified searching from databases of published and unpublished studies. The influence of pirfenidone, nintedanib and NAC on clinical outcomes, safety, and mortality was assessed via pair-wise meta-analysis. Ten papers (3847 IPF patients; 2254 treated; 1593 placebo) were included in this study. Our results showed that both pirfenidone and nintedanib, but not NAC, were significantly effective in reducing FVC decline and the risk of FVC ≥10% decline in percent predicted over 12 months. Nintenadib significantly protected against the risk of acute exacerbation and mortality. Pirfenidone and nintedanib showed a similar and good safety profile, whereas NAC provided a signal for increased adverse events. The rank of effectiveness emerging from this meta-analysis represents an indirect indicator of potential differences between currently approved doses of pirfenidone and nintedanib. Direct comparisons are necessary to assess this matter, and well designed bench-to-bedside studies would permit to understand the potential of combined, sequential, or adjunctive treatment regimens in which perhaps NAC may have a role for specific clusters of IPF patients. Copyright © 2016 Elsevier Ltd. All rights reserved.

Work zone performance monitoring application development, research summary.

DOT National Transportation Integrated Search

2016-10-01

In 2004, the Federal Highway Administration (FHWA) updated the work zone regulations to encourage the collection and use of work zone safety and mobility data (23 CFR 630 Subpart J). The new rule essentially requires agencies to use data to generate ...

Marine safety manual, volume 6 : ports and waterways activities

DOT National Transportation Integrated Search

1997-01-01

This Notice advises personnel assigned to Ports and Waterways Activities duties of the latest updated list of U.S. delegated authorities. Two new companies have been approved as delegated authorities and one3existing company has had their approval re...

Nevada Peer Exchange : Reno, NV, September 23-25, 2009

DOT National Transportation Integrated Search

2009-09-01

The Nevada Department of Transportation (NDOT) hosted a Peer Exchange of its Highway Safety Improvement Program (HSIP) on September 23-25, 2009. NDOT is updating their State HSIP Manual and initiated a peer exchange to share information and experienc...

A Checklist for Safe Schools.

ERIC Educational Resources Information Center

Schiffbauer, Pam

2000-01-01

School buildings ideally would have few exterior access points, no isolated hallways, and sunlit classrooms. A safety checklist recommends locating offices near main doors, monitoring hallway traffic, enhancing communications, updating crisis-management plans, teaching coping skills, standardizing dismissal policies, and ensuring legal compliance…

In-Vehicle Information Systems Demand Model (Research Update)

DOT National Transportation Integrated Search

2000-04-01

The goal of in-vehicle information system (IVIS) technologies is to increase the mobility, improve the efficiency, and increase the safety and/or convenience of the motoring public. To achieve this goal, IVISs must be designed to include good human f...

State Labor Legislation Enacted in 1973

ERIC Educational Resources Information Center

Levy, David A.

1974-01-01

The primary areas considered by State legislatures in 1973 included higher minimum wage rates and broader coverage of minimum wage laws, improved occupational safety, collective bargaining procedures for public employees, elimination of discrimination in employment, and updating of child labor standards. (Author)

Work-zone traffic performance measures : tech transfer summary.

DOT National Transportation Integrated Search

2013-09-01

The Federal Highway Administration (FHWA) 2004 Work Zone Safety and Mobility Rule applies to all state and local government agencies that receive federal-aid highway funding after October 12, 2007. This rule was an update to the former regulation (23...

Cost-outcome analysis in injury prevention and control: eighty-four recent estimates for the United States.

PubMed

Miller, T R; Levy, D T

2000-06-01

The objectives of this study were to review cost-outcome analyses in injury prevention and control and estimate associated benefit-cost ratios and cost per quality-adjusted life-year. Medline and Internet search, bibliographic review, and federal agency contacts identified published and unpublished studies from 1987 to 1998 for the United States. Studies of low quality and analyses of occupational, air, rail, and water transport safety programs were excluded. Selected results were recomputed to increase discount rate, benefit category, and benefit estimate comparability and to update injury incidence rates. More than half of the 84 injury prevention measures reviewed yielded net societal cost savings. Twelve measures had costs that exceeded benefits. Of 33 road safety measures analyzed, 19 yielded net cost savings. Of 34 violence prevention approaches studied, 19 yielded net cost savings, whereas 8 had costs that exceeded benefits. Interventions with the highest benefit-cost ratios included juvenile delinquent therapy programs, fire-safe cigarettes, federal road and traffic safety program funding, lane markers painted on roads, post-mounted reflectors on hazardous curves, safety belts in front seats, safety belt laws with primary enforcement, child safety seats, child bicycle helmets, enforcement of laws against serving alcohol to the intoxicated, substance abuse treatment, brief medical interventions with heavy drinkers, and a comprehensive safe communities program in a low-income neighborhood. Studies of cost-saving measures do not exist for several injury types. Injury prevention often can reduce medical costs and save lives. Wider implementation of proven measures is warranted.

Technologies and mechanisms for safety control of ready-to-eat muscle foods: an updated review.

PubMed

Jiang, Jiang; Xiong, Youling L

2015-01-01

Ready-to-eat (RTE) muscle foods refer to a general category of meat and poultry products that are fully cooked and consumable without reheating. These products, including whole and sliced pork, beef, turkey, chicken, and variety of meats, in the forms of ham, roast, rolls, sausage, and frankfurter, are widely available in the delicatessen section of retail stores or various food service outlets. However, difficulties in avoidance of contamination by foodborne pathogens, notably Listeria monocytogenes, during product postlethality repackaging render RTE meats labile to outbreaks. Accordingly, the USDA-FSIS has established processing guidelines and regulations, which are constantly updated, to minimize foodborne pathogens in RTE products. Technologies that complement good manufacturing practice have been developed to control RTE meat safety. Among them, various antimicrobial product formulations, postpackaging pasteurization (thermal and nonthermal), and antimicrobial packaging are being used. Through these efforts, outbreaks linked to RTE meat consumption have substantially reduced in recent years. However, the pervasive and virulent nature of L. monocytogenes and the possible presence of other cold-tolerant pathogens entail continuing developments of new intervention technologies. This review updates existing and emerging physical and chemical methods and their mode of action to inactivate or inhibit threatening microorganisms in RTE muscle foods.

Effectiveness of assistive technology in improving the safety of people with dementia: a systematic review and meta-analysis.

PubMed

Brims, Lucy; Oliver, Kathryn

2018-04-10

Assistive technology (AT) may enable people with dementia to live safely at home for longer, preventing care home admission. This systematic review assesses the effectiveness of AT in improving the safety of people with dementia living in the domestic setting, by searching for randomised controlled trials, non-randomised controlled trials and controlled before-after studies which compared safety AT with treatment as usual. Measures of safety include care home admission; risky behaviours, accidents and falls at home; and numbers of deaths. The review updates the safety aspect of Fleming and Sum's 2014 systematic review. Seven bibliographic databases, the Social Care Institute for Excellence website and the Alzheimer's Society website were searched for published and unpublished literature between 2011-2016. Search terms related to AT, dementia and older people. Common outcomes were meta-analysed. Three randomised controlled trials were identified, including 245 people with dementia. No significant differences were found between intervention and control groups in care home admission (risk ratio 0.85 95% CI [0.37, 1.97]; Z = 0.37; p = 0.71). The probability of a fall occurring was 50% lower in the intervention group (risk ratio 0.50 95% CI [0.32, 0.78]; Z = 3.03; p = 0.002). One included study found that a home safety package containing AT significantly reduced risky behaviour and accidents (F(45) = 4.504, p < 0.001). Limitations include the few studies found and the inclusion of studies in English only. AT's effectiveness in decreasing care home admission is inconclusive. However, the AT items and packages tested improved safety through reducing falls risk, accidents and other risky behaviour.

Stress attenuates the flexible updating of aversive value

PubMed Central

Raio, Candace M.; Hartley, Catherine A.; Orederu, Temidayo A.; Li, Jian; Phelps, Elizabeth A.

2017-01-01

In a dynamic environment, sources of threat or safety can unexpectedly change, requiring the flexible updating of stimulus−outcome associations that promote adaptive behavior. However, aversive contexts in which we are required to update predictions of threat are often marked by stress. Acute stress is thought to reduce behavioral flexibility, yet its influence on the modulation of aversive value has not been well characterized. Given that stress exposure is a prominent risk factor for anxiety and trauma-related disorders marked by persistent, inflexible responses to threat, here we examined how acute stress affects the flexible updating of threat responses. Participants completed an aversive learning task, in which one stimulus was probabilistically associated with an electric shock, while the other stimulus signaled safety. A day later, participants underwent an acute stress or control manipulation before completing a reversal learning task during which the original stimulus−outcome contingencies switched. Skin conductance and neuroendocrine responses provided indices of sympathetic arousal and stress responses, respectively. Despite equivalent initial learning, stressed participants showed marked impairments in reversal learning relative to controls. Additionally, reversal learning deficits across participants were related to heightened levels of alpha-amylase, a marker of noradrenergic activity. Finally, fitting arousal data to a computational reinforcement learning model revealed that stress-induced reversal learning deficits emerged from stress-specific changes in the weight assigned to prediction error signals, disrupting the adaptive adjustment of learning rates. Our findings provide insight into how stress renders individuals less sensitive to changes in aversive reinforcement and have implications for understanding clinical conditions marked by stress-related psychopathology. PMID:28973957

2010 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

Dumont, Alan G.

2010-01-01

this report provides a NASA Range Safety overview for current and potential range users. This report contains articles which cover a variety of subject areas, summaries of various NASA Range Safety Program activities conducted during the past year, links to past reports, and information on several projects that may have a profound impact on the way business will be done in the future. Specific topics discussed in the 2010 NASA Range Safety Annual Report include a program overview and 2010 highlights; Range Safety Training; Range Safety Policy revision; Independent Assessments; Support to Program Operations at all ranges conducting NASA launch/flight operations; a continuing overview of emerging range safety-related technologies; and status reports from all of the NASA Centers that have Range Safety responsibilities. Every effort has been made to include the most current information available. We recommend this report be used only for guidance and that the validity and accuracy of all articles be verified for updates. Once again, the web-based format was used to present the annual report.

NASA's Software Safety Standard

NASA Technical Reports Server (NTRS)

Ramsay, Christopher M.

2005-01-01

NASA (National Aeronautics and Space Administration) relies more and more on software to control, monitor, and verify its safety critical systems, facilities and operations. Since the 1960's there has hardly been a spacecraft (manned or unmanned) launched that did not have a computer on board that provided vital command and control services. Despite this growing dependence on software control and monitoring, there has been no consistent application of software safety practices and methodology to NASA's projects with safety critical software. Led by the NASA Headquarters Office of Safety and Mission Assurance, the NASA Software Safety Standard (STD-18l9.13B) has recently undergone a significant update in an attempt to provide that consistency. This paper will discuss the key features of the new NASA Software Safety Standard. It will start with a brief history of the use and development of software in safety critical applications at NASA. It will then give a brief overview of the NASA Software Working Group and the approach it took to revise the software engineering process across the Agency.

Evidence report : obstructive sleep apnea and commercial motor vehicle driver safety, updated review : 11/30/2011.

DOT National Transportation Integrated Search

2011-11-30

Driving is a complicated psychomotor performance that depends on fine coordination between the sensory and motor systems. Many health conditions exist which have the potential to impair perception, cognition (including alertness, attitude to risk, an...

Evidence report : obstructive sleep apnea and commercial motor vehicle driver safety, updated review : 11/30/2011.

DOT National Transportation Integrated Search

2011-11-11

Driving is a complicated psychomotor performance that depends on fine coordination between the sensory and motor systems. Many health conditions exist which have the potential to impair perception, cognition (including alertness, attitude to risk, an...

EPA Update on Gold King Mine Response Efforts for August 17, 2015

EPA Pesticide Factsheets

August 17th news release: EPA is committed to working closely with response agencies and state and local officials to ensure the safety of citizens, respond to concerns and to evaluate impact to water contaminated by the spill.

Development of Prototype Driver Models for Highway Design: Research Update

DOT National Transportation Integrated Search

1999-06-01

One of the high-priority research areas of the Federal Highway Administration (FHWA) is the development of the Interactive Highway Safety Design Model (IHSDM). The goal of the IHSDM research program is to develop a systematic approach that will allow...

The effects of commercial electronic variable message signs (CEVMS) on driver attention and distraction : an update

DOT National Transportation Integrated Search

2009-02-01

The present report reviews research concerning the possible effects of Commercial Electronic Variable Message Signs (CEVMS) used for outdoor advertising on driver safety. Such CEVMS displays are alternatively known as Electronic Billboards (EBB) and ...

78 FR 61446 - Schedule of Charges Outside the United States

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-03

... Aviation Safety Inspectors outside the United States. The advisory circular has been updated in accordance... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration [AC 187-1G] Schedule of Charges Outside the United States AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of...

75 FR 65401 - Schedule of Charges Outside the United States

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-22

... Aviation Safety Inspectors outside the United States. The advisory circular has been updated in accordance... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration [AC 187-1D] Schedule of Charges Outside the United States AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of...

An Update on the Progress of the Extended One-Generation Reproductive Protocol

EPA Science Inventory

Consistent with a more science-based approach assessing potential adverse effects of pesticides, the ILSI-HESI Agricultural Chemical Safety Assessment (ACSA) Technical Committee, proposed a new tiered toxicity testing strategy. This approach utilizes fewer animals and provides an...

Equal employment opportunity and affirmative employment for minorities, women, and people with disabilities : accomplishment report and updates, fiscal year '98

DOT National Transportation Integrated Search

1999-01-01

Contents: Introduction to the National Highway Traffic Safety Administration; Office of Civil Rights Organizational Strcture (NHTSA); Accountability Statement; Certification of Qualifications of EEO Officials; Organizational Chart for NHTSA (TAB); Ac...

76 FR 63623 - Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-13

... Nutritional Biomarker Report: transfat analysis; update on ATSDR Science Symposium; update on Camp LeJeune; update on Environmental Health Tracking; presentation on hydraulic fracking; global health updates...

The effects of electronic stability control (ESC) on crashes--an update.

PubMed

Høye, Alena

2011-05-01

The present study is an update of the meta-analysis by Erke (Erke, A., 2008. Effects of Electronic Stability Control (ESC) on accidents: a review of empirical evidence. Accident Analysis & Prevention, 40 (1), 167-173). Results from 12 studies of the effects of Electronic Stability Control (ESC) on the number of different types of crashes were summarized by means of meta-analysis. The results indicate that ESC prevents about 40% of all crashes involving loss of control. The greatest reductions were found for rollover crashes (-50%), followed by run-off-road (-40%) and single vehicle crashes (-25%). These results are however likely to be somewhat overestimated, especially for non-fatal crashes. Multiple vehicle crashes were found to be largely unchanged. Reductions were found for some types of multiple vehicle crashes. Rear-end collisions are unchanged or may increase. Fatal crashes involving pedestrians, bicycles or animals were found to increase as well. ESC was found to be more effective in preventing fatal crashes than non-fatal crashes. ESC is often found to be more effective in Sports Utility Vehicles (SUVs) than in passenger cars. This may be due to differences between drivers of SUVs and passenger cars. The results from meta-analysis indicate that drivers of ESC-equipped vehicles are likely to be safer drivers than other drivers. All the same, ESC may lead to behavioural adaptation in some cases, but it is not likely that behavioural adaptation offsets the positive safety effects. This may be due to a lack of knowledge about ESC. Copyright © 2010 Elsevier Ltd. All rights reserved.

Los Alamos National Laboratory SAVY-4000 Field Surveillance Plan Update for 2016

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kelly, Elizabeth J.; Stone, Timothy Amos; Smith, Paul Herrick

The Packaging Surveillance Program section of the Department of Energy (DOE) Manual 441.1-1, Nuclear Material Packaging Manual (DOE 2008), requires DOE contractors to “ensure that a surveillance program is established and implemented to ensure the nuclear material storage package continues to meet its design criteria.” The Los Alamos National Laboratory (LANL) SAVY-4000 Field Surveillance Plan was first issued in FY 2013 (Kelly et al. 2013). The surveillance plan is reviewed annually and updated as necessary based on SAVY-4000 surveillance and other surveillance findings, as well as results of the lifetime extension studies (Blair et al. 2012, Weis et al. 2015a).more » The LANL SAVY-4000 Field Surveillance Plan Update was issued in 2014 (Kelly et al. 2014). This 2016 update reflects changes to the surveillance plan resulting from restrictions on handling residue materials greater than 500 g, the addition of specific engineering judgment containers, and 2015 surveillance findings. The SAVY-4000 container has a design life of five years, which was chosen as a conservative estimate of the functional properties of the materials used in the construction of the SAVY 4000 when exposed to the potential insults including temperature, corrosive materials and gases, and radiation. The SAVY-4000 container design basis is described in a safety analysis report (Anderson et al. 2013). In the National Nuclear Security Administration's (NNSA’s) approval of the safety analysis report, it was recommended that the design life clock begin on March 2014 (Nez et al. 2014). However, it is expected that a technical basis can be developed to extend the design life of the SAVY-4000 containers to approximately 40 years (Blair et al. 2012, Weis et al. 2015a). This surveillance plan update covers five years (2015–2019) and is developed to ensure SAVY-4000 containers meet their design criteria over the current five-year design life and to gather data that can be used in developing the technical basis for a 40-year design life. The technical basis for the longer design life will be developed based on the results of this surveillance plan and the concurrent lifetime extension studies (Blair et al. 2012, Weis et al. 2015a). A long-term surveillance plan will be developed by the completion of this plan and will be based on the results of the first several years of this five-year surveillance plan and the lifetime extension studies. In addition, the current Hagan container population is so large (approximately 3,500 LANL-wide, approximately 3,000 in PF-4) that it is anticipated Hagan containers will be in use for many years to come. Therefore, this plan includes surveillance activities for the Hagan container system during the time it takes to replace the Hagan containers with manually-compliant containers such as the SAVY 4000. These Hagan examinations not only provide information to determine if additional Hagan surveillance is needed, but also support SAVY lifetime-extension studies because some of the container components are made from similar material (e.g., stainless steel and Viton).« less

Promoting the safety performance of industrial radiography using a quantitative assessment system.

PubMed

Kardan, M R; Mianji, F A; Rastkhah, N; Babakhani, A; Azad, S Borhan

2006-12-01

The increasing number of industrial radiographers and their considerable occupational exposure has been one of the main concerns of the Iran Nuclear Regulatory Authority (INRA) in recent years. In 2002, a quantitative system of evaluating the safety performance of licensees and a complementary enforcement system was introduced by the National Radiation Protection Department (NRPD). Each parameter of the practice is given a weighting factor according to its importance to safety. Assessment of the licensees is done quantitatively by summing up their scores using prepared tables. Implementing this system of evaluation showed a considerable decrease in deficiencies in the various centres. Tables are updated regularly as a result of findings during the inspections. This system is used in addition to enforcement to promote safety performance and to increase the culture of safety in industrial radiography.

Memantine for Alzheimer's Disease: An Updated Systematic Review and Meta-analysis.

PubMed

Kishi, Taro; Matsunaga, Shinji; Oya, Kazuto; Nomura, Ikuo; Ikuta, Toshikazu; Iwata, Nakao

2017-01-01

The clinical benefit of memantine for Alzheimer's disease (AD) remains inconclusive. We performed an updated systematic review and meta-analysis of the efficacy/safety of memantine in AD. We included randomized trials of memantine for AD patients. Cognitive function scores (CF), behavioral disturbances scores (BD), and all-cause discontinuation were used as primary measures. Effect size based on a random-effects model was evaluated in the meta-analyses. Thirty studies (n = 7,567; memantine versus placebo: N = 11, n = 3,298; memantine + cholinesterase inhibitors (M+ChEIs) versus ChEIs: N = 17, n = 4,175) were identified. Memantine showed a significant improvement in CF [standardized mean difference (SMD) = -0.24, 95% confidence intervals (95% CIs) = -0.34, -0.15, p < 0.00001, I2 = 35% ] and BD (SMD = -0.16, 95% CIs = -0.29, -0.04, p = 0.01, I2 = 52%) compared with placebo. In the sensitivity analysis including only patients with moderate-severe AD, memantine was superior to the placebo in reducing BD without considerable heterogeneity (SMD = -0.20, 95% CIs = -0.34, -0.07, p = 0.003, I2 = 36%). Compared with ChEIs, M+ChEIs showed a greater reduction in BD (SMD = -0.20, 95% CIs = -0.36, -0.03, p = 0.02, I2 = 77%) and a trend of CF improvement (SMD = -0.11, 95% CIs = -0.22, 0.01, p = 0.06, I2 = 56%). However, in the sensitivity analysis of double-blind, placebo-controlled studies only, M+ChEIs showed a significant reduction in BD compared with ChEIs without considerable heterogeneity (SMD = -0.11, 95% CIs = -0.21, -0.01, p = 0.04, I2 = 40%). When performing the sensitivity analysis of donepezil studies only, M+ChEIs was superior to ChEIs in improving CF without considerable heterogeneity (SMD = -0.18, 95% CIs = -0.31, -0.05, p = 0.006, I2 = 49%). No differences were detected in all-cause discontinuation between the groups. The meta-analyses suggest the credible efficacy and safety of memantine in treating AD when used alone or in combination with ChEIs.

RELAP-7 Development Updates

DOE Office of Scientific and Technical Information (OSTI.GOV)

Zhang, Hongbin; Zhao, Haihua; Gleicher, Frederick Nathan

RELAP-7 is a nuclear systems safety analysis code being developed at the Idaho National Laboratory, and is the next generation tool in the RELAP reactor safety/systems analysis application series. RELAP-7 development began in 2011 to support the Risk Informed Safety Margins Characterization (RISMC) Pathway of the Light Water Reactor Sustainability (LWRS) program. The overall design goal of RELAP-7 is to take advantage of the previous thirty years of advancements in computer architecture, software design, numerical methods, and physical models in order to provide capabilities needed for the RISMC methodology and to support nuclear power safety analysis. The code is beingmore » developed based on Idaho National Laboratory’s modern scientific software development framework – MOOSE (the Multi-Physics Object-Oriented Simulation Environment). The initial development goal of the RELAP-7 approach focused primarily on the development of an implicit algorithm capable of strong (nonlinear) coupling of the dependent hydrodynamic variables contained in the 1-D/2-D flow models with the various 0-D system reactor components that compose various boiling water reactor (BWR) and pressurized water reactor nuclear power plants (NPPs). During Fiscal Year (FY) 2015, the RELAP-7 code has been further improved with expanded capability to support boiling water reactor (BWR) and pressurized water reactor NPPs analysis. The accumulator model has been developed. The code has also been coupled with other MOOSE-based applications such as neutronics code RattleSnake and fuel performance code BISON to perform multiphysics analysis. A major design requirement for the implicit algorithm in RELAP-7 is that it is capable of second-order discretization accuracy in both space and time, which eliminates the traditional first-order approximation errors. The second-order temporal is achieved by a second-order backward temporal difference, and the one-dimensional second-order accurate spatial discretization is achieved with the Galerkin approximation of Lagrange finite elements. During FY-2015, we have done numerical verification work to verify that the RELAP-7 code indeed achieves 2nd-order accuracy in both time and space for single phase models at the system level.« less

The Safety and Efficacy of Laparoscopic Common Bile Duct Exploration Combined with Cholecystectomy for the Management of Cholecysto-choledocholithiasis: An Up-to-date Meta-analysis.

PubMed

Pan, Long; Chen, Mingyu; Ji, Lin; Zheng, Longbo; Yan, Peijian; Fang, Jing; Zhang, Bin; Cai, Xiujun

2018-03-12

The aim of this study was to compare the efficacy and safety of the laparoscopic common bile duct exploration (LCBDE) and laparoscopic cholecystectomy (LC) with preoperative endoscopic sphincterotomy (pre-EST) and LC for concomitant gallstones and common bile duct (CBD) stones. It remains controversial whether LCBDE+LC is better than pre-EST+LC for gallstones and CBD stones. A specific search of online databases was performed from January 2006 to October 2017. Relative outcomes of perioperative safety and postoperative efficacy were synthesized. Single-arm meta-analysis and cumulative meta-analysis were also conducted. A total of 13 studies involving 1757 (872 vs 885) patients were included for analysis in our study. The CBD stones clearance rate [94.1% vs 90.1%; odds ratio (OR) 1.56, P = 0.012] was significantly higher in patients who underwent LCBDE+LC than pre-EST+LC, while perioperative complications (7.6% vs 12.0%; OR 0.67, P = 0.015), conversion to other procedure (4.1% vs 7.1%; OR 0.64, P = 0.025), retained stones rate (1.2% vs 7.9%; OR 0.34, P = 0.004), lithiasis recurrence rate (1.8% vs 5.6%, OR 0.32, P = 0.005), operative time [112.28 vs 132.03 minutes; weighted mean difference (WMD) -18.08, P = 0.002], length of hospital stay (4.94 vs 6.62 days; WMD -1.63, P = 0.023), and total charges [standardized mean difference (SMD) -2.76, P = 0.002] were significantly lower in LCBDE+LC. The mortality (0.6% vs 1.1%; OR 0.32, P = 0.117) was similar between the 2 groups. The cumulative meta-analyses indicated the effect sizes of CBD stones clearance rate, perioperative complications, and conversion to other procedure have already stabilized between 2 groups. The updated meta-analysis first confirms that LCBDE+LC is superior to pre-EST+LC both in perioperative safety and short- and long-term postoperative efficacy, which should be considered as optimal treatment choice for cholecysto-choledocholithiasis.

78 FR 48079 - Proposed Amendment of Class E Airspace; Danville, VA

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-07

... Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: This action...). This action would enhance the safety and airspace management of Instrument Flight Rules (IFR) operations at the airport. This action also would update the airport's geographic coordinates. DATES...

Open Source Surrogate Safety Assessment Model, 2017 Enhancement and Update: SSAM Version 3.0 [Tech Brief

DOT National Transportation Integrated Search

2016-11-17

The ETFOMM (Enhanced Transportation Flow Open Source Microscopic Model) Cloud Service (ECS) is a software product sponsored by the U.S. Department of Transportation in conjunction with the Microscopic Traffic Simulation Models and SoftwareAn Op...

State Requirements for Educational Facilities, 1997.

ERIC Educational Resources Information Center

Florida State Dept. of Education, Tallahassee. Office of Educational Facilities.

This document updates Florida's deregulation of construction of educational facilities guidelines, while keeping as the primary focus the safety of the students in pre-K through community college facilities. Organized by the sequence of steps required in the facilities procurement process, it covers general definitions, property…

75 FR 72877 - Pipeline Safety: Updates to Pipeline and Liquefied Natural Gas Reporting Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-26

... liquid pipelines, and liquefied natural gas (LNG) facilities. These revisions will enhance PHMSA's... of natural gas pipelines, hazardous liquid pipelines, and LNG facilities. Specifically, PHMSA... commodity transported, and type of commodity transported. 8. Modify hazardous liquid operator telephonic...

Updated review of potential test procedures for FMVSS no.208

DOT National Transportation Integrated Search

1999-10-01

The objective of a crash test for Federal Motor Vehicle Safety Standard (FMVSS) No. 208 is to measure how well a passenger vehicle would protect its occupants in the event of a serious real world frontal crash. The ideal frontal crash procedure will ...

75 FR 82400 - Stakeholders Meeting To Provide Updates on NIOSH-Funded Research, Certification and Standards...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-30

... Technology Use in Industry Sectors AGENCY: National Institute for Occupational Safety and Health (NIOSH...), Personal Protective Technology (PPT) Program and National Personal Protective Technology Laboratory (NPPTL... explore personal protective technology use in industry sectors. In addition, conformity assessment...

75 FR 35099 - Privacy Act of 1974: Update and Amend System of Records

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-21

... result in a contrary determination. ADDRESSES: Send written comments to the Group Manager, Employee... INFORMATION CONTACT: Willie Powers, Group Manager, [email protected] . SUPPLEMENTARY INFORMATION: The... medical, personnel, dispensary, health, safety, or other designated offices within the agency, or...

76 FR 56128 - Retrospective Review of Existing Regulations

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-12

..., welfare, safety, and our environment while promoting economic growth, innovation, competitiveness, and job creation.'' In furtherance of its ongoing efforts to update regulations to reflect market developments and... Commission in considering the development of a plan for the retrospective review of its regulations. DATES...

Gender Equity: Still Knocking at the Classroom Door.

ERIC Educational Resources Information Center

Sadker, David

1999-01-01

Subtlety and complacency mask ongoing gender bias in today's classrooms. Updates are presented concerning career segregation; single-sex classrooms; safety and health problems; dropout rates; gifted programs; male/female stereotypes; classroom interactions; SAT scores; math, science and technology gender gaps; political reversals; and female…

Emerging Approaches and Opportunities to inform Internal Dosimetry and Inter-individual Variability

EPA Science Inventory

This talk provided an update to EPA ORD scientists and program officers about planned research within the Chemical Safety for Sustainability program to address chemical toxicokinetics and strategies to understand better the range of variability across different populations and li...

NASIS data base management system - IBM 360/370 OS MVT implementation. 7: Data base administrator user's guide

NASA Technical Reports Server (NTRS)

1973-01-01

The Data Base Administrator User's Guide for the NASA Aerospace Safety information system is presented. The subjects discussed are: (1) multi-terminal tasking, (2) data base executive, (3) utilities, (4) maintenance, and (5) update mode functions.

Chemical and Biological Terrorism: Current Updates for Nurse Educators.

ERIC Educational Resources Information Center

Veenema, Tener Goodwin

2002-01-01

Describes eight topics related to chemical/biological terrorism for a standalone nursing course or integration into other courses: surveillance systems; identification, communication, and response; chemical agents; biological agents; recognition of covert exposure; patient decontamination and mass triage; availability and safety of therapies; and…

NIEHS/FDA CLARITY-BPA research program update.

PubMed

Heindel, Jerrold J; Newbold, Retha R; Bucher, John R; Camacho, Luísa; Delclos, K Barry; Lewis, Sherry M; Vanlandingham, Michelle; Churchwell, Mona I; Twaddle, Nathan C; McLellen, Michelle; Chidambaram, Mani; Bryant, Matthew; Woodling, Kellie; Gamboa da Costa, Gonçalo; Ferguson, Sherry A; Flaws, Jodi; Howard, Paul C; Walker, Nigel J; Zoeller, R Thomas; Fostel, Jennifer; Favaro, Carolyn; Schug, Thaddeus T

2015-12-01

Bisphenol A (BPA) is a chemical used in the production of numerous consumer products resulting in potential daily human exposure to this chemical. The FDA previously evaluated the body of BPA toxicology data and determined that BPA is safe at current exposure levels. Although consistent with the assessment of some other regulatory agencies around the world, this determination of BPA safety continues to be debated in scientific and popular publications, resulting in conflicting messages to the public. Thus, the National Toxicology Program (NTP), National Institute of Environmental Health Sciences (NIEHS), and U.S. Food and Drug Administration (FDA) developed a consortium-based research program to link more effectively a variety of hypothesis-based research investigations and guideline-compliant safety testing with BPA. This collaboration is known as the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA). This paper provides a detailed description of the conduct of the study and a midterm update on progress of the CLARITY-BPA research program. Published by Elsevier Inc.

NIEHS/FDA CLARITY-BPA research program update

PubMed Central

Heindel, Jerrold J.; Newbold, Retha R.; Bucher, John R.; Camacho, Luísa; Delclos, K. Barry; Lewis, Sherry M.; Vanlandingham, Michelle; Churchwell, Mona I.; Twaddle, Nathan C.; McLellen, Michelle; Chidambaram, Mani; Bryant, Matthew; Woodling, Kellie; Gamboa da Costa, Gonçalo; Ferguson, Sherry A.; Flaws, Jodi; Howard, Paul C.; Walker, Nigel J.; Zoeller, R. Thomas; Fostel, Jennifer; Favaro, Carolyn; Schug, Thaddeus T.

2016-01-01

Bisphenol A (BPA) is a chemical used in the production of numerous consumer products resulting in potential daily human exposure to this chemical. The FDA previously evaluated the body of BPA toxicology data and determined that BPA is safe at current exposure levels. Although consistent with the assessment of some other regulatory agencies around the world, this determination of BPA safety continues to be debated in scientific and popular publications, resulting in conflicting messages to the public. Thus, the National Toxicology Program (NTP), National Institute of Environmental Health Sciences (NIEHS), and U.S Food and Drug Administration (FDA) developed a consortium-based research program to link more effectively a variety of hypothesis-based research investigations and guideline-compliant safety testing with BPA. This collaboration is known as the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA). This paper provides a detailed description of the conduct of the study and a midterm update on progress of the CLARITY-BPA research program. PMID:26232693

IRQN award paper: Operational rounds: a practical administrative process to improve safety and clinical services in radiology.

PubMed

Donnelly, Lane F; Dickerson, Julie M; Lehkamp, Todd W; Gessner, Kevin E; Moskovitz, Jay; Hutchinson, Sally

2008-11-01

As part of a patient safety program in the authors' department of radiology, operational rounds have been instituted. This process consists of radiology leaders' visiting imaging divisions at the site of imaging and discussing frontline employees' concerns about patient safety, the quality of care, and patient and family satisfaction. Operational rounds are executed at a time to optimize the number of attendees. Minutes that describe the issues identified, persons responsible for improvement, and updated improvement plan status are available to employees online. Via this process, multiple patient safety and other issues have been identified and remedied. The authors believe that the process has improved patient safety, the quality of care, and the efficiency of operations. Since the inception of the safety program, the mean number of days between serious safety events involving radiology has doubled. The authors review the background around such walk rounds, describe their particular program, and give multiple illustrative examples of issues identified and improvement plans put in place.

Updating OSHA Standards Based on National Consensus Standards; Eye and Face Protection. Final rule.

PubMed

2016-03-25

On March 13, 2015, OSHA published in the Federal Register a notice of proposed rulemaking (NPRM) to revise its eye and face protection standards for general industry, shipyard employment, marine terminals, longshoring, and construction by updating the references to national consensus standards approved by the American National Standards Institute (ANSI). OSHA received no significant objections from commenters and therefore is adopting the amendments as proposed. This final rule updates the references in OSHA's eye and face standards to reflect the most recent edition of the ANSI/International Safety Equipment Association (ISEA) eye and face protection standard. It removes the oldest-referenced edition of the same ANSI standard. It also amends other provisions of the construction eye and face protection standard to bring them into alignment with OSHA's general industry and maritime standards.

How do smoking cessation medicines compare with respect to their neuropsychiatric safety? A protocol for a systematic review, network meta-analysis and cost-effectiveness analysis.

PubMed

Thomas, Kyla H; Caldwell, Deborah; Dalili, Michael N; Gunnell, David; Munafò, Marcus R; Stevenson, Matt; Welton, Nicky J

2017-06-17

Cigarette smoking is one of the leading causes of early death in the UK and worldwide. Public health guidance recommends the use of varenicline, bupropion and nicotine replacement therapy (NRT) as smoking cessation aids in the UK. Additionally, the first electronic cigarette has been licensed for use as a smoking cessation medicine. However, there are ongoing concerns about the safety of these medicines. We present a protocol for a systematic review and network meta-analysis (NMA) to determine how these smoking cessation medicines compare to each other with respect to their neuropsychiatric safety in adult smokers. Secondary aims include updating the evidence regarding the effectiveness and cardiovascular safety of these medicines for use in a cost-effectiveness analysis. We will include randomised controlled trials and observational studies with control groups comparing monotherapy with varenicline, bupropion, NRT or electronic cigarette and combination therapies to each other, placebo or usual care. The primary composite safety outcome will be serious adverse events, defined as events that resulted in death, were life threatening, required hospitalisation or resulted in significant disability or congenital/birth defect. The preferred effectiveness outcome will be sustained smoking cessation defined as abstinence for a minimum of 6 months as determined by biochemical validation. We will include trials identified by previous reviews and search relevant databases for newly published trials as well as contacting study authors to identify unpublished information. We will conduct fixed-effect and random-effect meta-analyses for each pairwise comparison of treatments and outcome; where these estimates differ, we will consider reasons for heterogeneity, quantified using the between-study variance (τ 2 ). For each outcome, we will construct a NMA in a Bayesian framework which will be compared with the pair-wise results, allowing us to rank treatments. The effectiveness estimates from the NMA will be entered into a probabilistic economic model. Ethics approval is not required for this evidence synthesis study as it involves analysis of secondary data from randomised controlled trials and observational studies. The review will make an important contribution to the knowledge base around the effectiveness, safety and cost-effectiveness of smoking cessation medicines. Results will be disseminated to the general public, healthcare practitioners and clinicians, academics, industry and policy makers. CRD42016041302. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Space Mission Human Reliability Analysis (HRA) Project

NASA Technical Reports Server (NTRS)

Boyer, Roger

2014-01-01

The purpose of the Space Mission Human Reliability Analysis (HRA) Project is to extend current ground-based HRA risk prediction techniques to a long-duration, space-based tool. Ground-based HRA methodology has been shown to be a reasonable tool for short-duration space missions, such as Space Shuttle and lunar fly-bys. However, longer-duration deep-space missions, such as asteroid and Mars missions, will require the crew to be in space for as long as 400 to 900 day missions with periods of extended autonomy and self-sufficiency. Current indications show higher risk due to fatigue, physiological effects due to extended low gravity environments, and others, may impact HRA predictions. For this project, Safety & Mission Assurance (S&MA) will work with Human Health & Performance (HH&P) to establish what is currently used to assess human reliabiilty for human space programs, identify human performance factors that may be sensitive to long duration space flight, collect available historical data, and update current tools to account for performance shaping factors believed to be important to such missions. This effort will also contribute data to the Human Performance Data Repository and influence the Space Human Factors Engineering research risks and gaps (part of the HRP Program). An accurate risk predictor mitigates Loss of Crew (LOC) and Loss of Mission (LOM).The end result will be an updated HRA model that can effectively predict risk on long-duration missions.

Sublingual immunotherapy: World Allergy Organization position paper 2013 update.

PubMed

Canonica, Giorgio Walter; Cox, Linda; Pawankar, Ruby; Baena-Cagnani, Carlos E; Blaiss, Michael; Bonini, Sergio; Bousquet, Jean; Calderón, Moises; Compalati, Enrico; Durham, Stephen R; van Wijk, Roy Gerth; Larenas-Linnemann, Désirée; Nelson, Harold; Passalacqua, Giovanni; Pfaar, Oliver; Rosário, Nelson; Ryan, Dermot; Rosenwasser, Lanny; Schmid-Grendelmeier, Peter; Senna, Gianenrico; Valovirta, Erkka; Van Bever, Hugo; Vichyanond, Pakit; Wahn, Ulrich; Yusuf, Osman

2014-03-28

We have prepared this document, "Sublingual Immunotherapy: World Allergy Organization Position Paper 2013 Update", according to the evidence-based criteria, revising and updating chapters of the originally published paper, "Sublingual Immunotherapy: World Allergy Organization Position Paper 2009", available at http://www.waojournal.org. Namely, these comprise: "Mechanisms of sublingual immunotherapy;" "Clinical efficacy of sublingual immunotherapy" - reporting all the data of all controlled trials published after 2009; "Safety of sublingual immunotherapy" - with the recently published Grading System for adverse reactions; "Impact of sublingual immunotherapy on the natural history of respiratory allergy" - with the relevant evidences published since 2009; "Efficacy of SLIT in children" - with detailed analysis of all the studies; "Definition of SLIT patient selection" - reporting the criteria for eligibility to sublingual immunotherapy; "The future of immunotherapy in the community care setting"; "Methodology of clinical trials according to the current scientific and regulatory standards"; and "Guideline development: from evidence-based medicine to patients' views" - including the evolution of the methods to make clinical recommendations.Additionally, we have added new chapters to cover a few emerging crucial topics: "Practical aspects of schedules and dosages and counseling for adherence" - which is crucial in clinical practice for all treatments; "Perspectives and new approaches" - including recombinant allergens, adjuvants, modified allergens, and the concept of validity of the single products. Furthermore, "Raising public awareness about sublingual immunotherapy", as a need for our patients, and strategies to increase awareness of allergen immunotherapy (AIT) among patients, the medical community, all healthcare stakeholders, and public opinion, are also reported in detail.

Florida Best Practice Psychotherapeutic Medication Guidelines for Adults With Major Depressive Disorder.

PubMed

McIntyre, Roger S; Suppes, Trisha; Tandon, Rajiv; Ostacher, Michael

2017-06-01

Herein we provide the 2015 update for the Florida Best Practice Psychotherapeutic Medication Guidelines (FPG) for major depressive disorder (MDD). The FPG represent evidence-based decision support for practitioners providing care to adults with MDD. The consensus meeting included representatives from the Florida Agency for Health Care Administration (FAHCA), advocacy members, academic experts in MDD, and multidisciplinary mental health clinicians, as well as health policy experts. The FAHCA provided funding support for the FPG. Evidence was limited to results from adequately powered, randomized, double-blind, placebo-controlled trials; in addition, pooled-, meta-, and network-analyses were included. Recommendations were based on consensus arrived at by the multistakeholder Florida Expert Panel. Articles selected were identified on the electronic search engine PubMed with the dates 2010 to present. The search terms were major depressive disorder, psychopharmacology, antidepressants, psychotherapy, neuromodulation, complementary alternative medicines, pooled-analysis, meta-analysis, and network-analysis. Bibliographies of the identified articles were manually searched for additional citations not identified in the original search. A consensus meeting comprising all representatives took place on September 25-26, 2015, in Tampa, Florida. Guiding principles (eg, emphasis on the most rigorous evidence for efficacy, safety, and tolerability) were discussed, defined, and operationalized prior to review of extant data. As MDD often pursues a recurrent and chronic course, principles of practice, measurement-based care, and comprehensive assessment and management of overall physical and mental health were emphasized. Evidence supporting pretreatment major depressive episode specifiers (eg, mixed features, anxious distress) and the role of pharmacogenomics (and other biological-behavioral markers) in informing treatment selection were comprehensively discussed. Algorithmic priority was assigned to agents with relatively greater therapeutic index (ie, efficacy) and minimal propensity for safety and tolerability disadvantages. The updated 2015 FPG provide concise, pragmatic, evidence-based decision support for treatment selection and sequencing for adults with MDD. Principles of practice include measurement-based care, priority to both psychiatric and medical comorbidity, identification of DSM-5-defined specifiers (eg, mixed features), suicide risk assessment, and evaluation of cognitive symptoms. The FPG have purposefully aimed to minimize emphasis on "expert opinion" and instead differentially emphasized extant evidence for pharmacologic treatments. © Copyright 2017 Physicians Postgraduate Press, Inc.

Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer.

PubMed

Hortobagyi, G N; Stemmer, S M; Burris, H A; Yap, Y S; Sonke, G S; Paluch-Shimon, S; Campone, M; Petrakova, K; Blackwell, K L; Winer, E P; Janni, W; Verma, S; Conte, P; Arteaga, C L; Cameron, D A; Mondal, S; Su, F; Miller, M; Elmeliegy, M; Germa, C; O'Shaughnessy, J

2018-04-27

The phase III MONALEESA-2 study demonstrated significantly prolonged progression-free survival (PFS) and a manageable toxicity profile for first-line ribociclib plus letrozole versus placebo plus letrozole in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. Here we report updated efficacy and safety data, together with exploratory biomarker analyses, from the MONALEESA-2 study. A total of 668 postmenopausal women with HR+, HER2- recurrent/metastatic breast cancer were randomized (1:1; stratified by presence/absence of liver and/or lung metastases) to ribociclib (600 mg/day; 3-weeks-on/1-week-off; 28-day treatment cycles) plus letrozole (2.5 mg/day; continuous) or placebo plus letrozole. The primary endpoint was locally assessed PFS. The key secondary endpoint was overall survival (OS). Other secondary endpoints included overall response rate (ORR) and safety. Biomarker analysis was an exploratory endpoint. At the time of the second interim analysis, the median duration of follow-up was 26.4 months. Median PFS was 25.3 months (95% confidence interval [CI], 23.0-30.3) for ribociclib plus letrozole and 16.0 months (95% CI, 13.4-18.2) for placebo plus letrozole (hazard ratio 0.568; 95% CI, 0.457-0.704; log-rank P=9.63 × 10-8). Ribociclib treatment benefit was maintained irrespective of PIK3CA or TP53 mutation status, total Rb, Ki67, or p16 protein expression, and CDKN2A, CCND1, or ESR1 mRNA levels. Ribociclib benefit was more pronounced in patients with wild-type versus altered receptor tyrosine kinase genes. OS data remain immature, with 116 deaths observed; 50 in the ribociclib arm and 66 in the placebo arm (hazard ratio: 0.746; 95% CI, 0.517-1.078). The ORR was 42.5% versus 28.7% for all patients treated with ribociclib plus letrozole versus placebo plus letrozole, respectively, and 54.5% versus 38.8%, respectively, for patients with measurable disease. Safety results, after a further 11.1 months of follow-up, were comparable with those reported at the first analysis, with no new or unexpected toxicities observed, and no evidence of cumulative toxicity. The improved efficacy outcomes and manageable tolerability observed with first-line ribociclib plus letrozole are maintained with longer follow-up, relative to letrozole monotherapy. NCT01958021.

Attitudes and Opinions of Doctors of Chiropractic Specializing in Pediatric Care Toward Patient Safety: A Cross-sectional Survey.

PubMed

Pohlman, Katherine A; Carroll, Linda; Hartling, Lisa; Tsuyuki, Ross; Vohra, Sunita

2016-09-01

The purpose of this cross-sectional survey was to evaluate attitudes and opinions of doctors of chiropractic (DCs) specializing in pediatric care toward patient safety. The Medical Office Survey on Patient Safety Culture of the Agency for Healthcare Research and Quality was adapted for providers who use spinal manipulation therapy and sent out to 2 US chiropractic organizations' pediatric council members (n = 400) between February and April 2014. The survey measured 12 patient safety dimensions and included questions on patient safety items and quality issues, information exchange, and overall clinic ratings. Data analyses included a percent composite average and a nonrespondent analysis. The response rate was 29.5% (n = 118). Almost one- third of respondents' patients were pediatric (≤17 years of age). DCs with a pediatric certification were 3 times more likely to respond (P < .001), but little qualitative differences were found in responses. The patient safety dimensions with the highest positive composite percentages were Organizational Learning (both administration and clinical) and Teamwork (>90%). Patient Care Tracking/Follow-up and Work Pressure and Pace were patient safety dimensions that had the lowest positive composite scores (<85%). The responses also indicated that there was concern regarding information exchange with insurance/third-party payors. Two quality issues identified for improvement were (1) updating a patient's medication list and (2) following up on critically abnormal results from a laboratory or imaging test within 1 day. The average overall patient safety rating score indicated that 83% of respondents rated themselves as "very good" or "excellent." Compared with 2014 Agency for Healthcare Research and Quality physician referent data from medical offices, pediatric DCs appear to have more positive patient safety attitudes and opinions. Future patient safety studies need to prospectively evaluate safety performance with direct feedback from patients and compare results with these self-assessed safety attitudes, as well as make further use of this survey to develop a comparable database for spinal manipulation providers. Copyright © 2016. Published by Elsevier Inc.

Metformin treatment of type 2 diabetes mellitus in pregnancy: update on safety and efficacy.

PubMed

Polasek, Thomas M; Doogue, Matthew P; Thynne, Tilenka R J

2018-06-01

With the increasing prevalence of type 2 diabetes mellitus (T2DM) in women of childbearing age, prescribing antidiabetic medications in first-trimester pregnancy is becoming more common. Metformin treatment during this time is usually avoided in countries with well-resourced healthcare. This is based on historical concerns about safety to the foetus and the widespread availability of insulin. However, there is now increasing interest in the potential benefits of metformin in pregnant women with T2DM. In this commentary, the main evidence supporting metformin safety in pregnancy is summarized, with an emphasis on the first trimester. Based on a structured literature search, the recent randomized controlled trials comparing metformin and insulin are reviewed. We then show that prescribing advice for metformin in pregnancy is inconsistent and product information/package inserts (PI) are universally out of date. This causes confusion and pushes some women and their clinicians to change from metformin to insulin. The potential advantages of metformin in pregnant women with T2DM are then discussed, including oral dosing and improved acceptability, lower resource utilization and cost, decreased insulin requirements, less maternal weight gain and less risk of maternal and neonatal hypoglycaemia. The conclusion is that metformin is a cheap and efficacious antidiabetic medication for many pregnant women with T2DM, with reasonable evidence for safety. Drug information resources should be updated so that metformin can be considered more broadly in women with T2DM who present for antenatal care.

The Clery Act on Campus: Status Update and Gender Implications

ERIC Educational Resources Information Center

Lee, E. Ashleigh Schuller

2017-01-01

This chapter provides a summary of the history of the Clery Act and reviews the latest developments of the Violence Against Women Reauthorization Act. In light of this legislation, campus collaboration should occur to ensure students' safety and institutional legal compliance regarding mandatory reporting requirements.

Work zone impacts assessment : an approach to assess and management work zone safety and mobility impacts of road projects

DOT National Transportation Integrated Search

2006-05-01

To help transportation agencies understand and implement the provisions of the Rule, FHWA has : developed four guidance documents. This Guide is designed to help transportation agencies : develop and/or update their own policies, processes, and proce...

78 FR 72010 - Establishment of Class E Airspace; Magee, MS

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-02

... safety and airspace management of Instrument Flight Rules (IFR) operations within the National Airspace System. This action also updates the geographic coordinates of the airport. DATES: Effective 0901 UTC.... Subsequent to publication, the FAA found an error in the geographic coordinates of Magee Municipal Airport...

78 FR 58897 - Pipeline Safety: Administrative Procedures; Updates and Technical Corrections

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-25

... incorporate increased transparency into the decision making process, the regulations must explicitly recognize... certainty, and due process. II. Discussion of Comments The comments received from the trade organizations... assistance through these processes by assisting OPS in the development of written responses to requests for...

76 FR 47078 - Make Inoperative Exemptions; Vehicle Modifications To Accommodate People With Disabilities, Head...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-04

... Accommodate People With Disabilities, Head Restraints AGENCY: National Highway Traffic Safety Administration... in the context of vehicle modifications to accommodate people with disabilities. The rule facilitates the mobility of drivers and passengers with disabilities by updating the exemption to include the...

Crash avoidance needs and countermeasure profiles for safety applications based on light-vehicle-to-pedestrian communications

DOT National Transportation Integrated Search

2016-08-01

This research supports establishing an updated understanding of the pedestrian crash problem and defining a way to connect the crash problem with vehicle-to-pedestrian (V2P) communication crash avoidance technology. It describes 5 priority pre-crash ...

76 FR 73687 - Advisory Committee on Construction Safety and Health (ACCSH)

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-29

... update personal protective equipment standards on head protection for construction work (29 CFR 1926.100..., including any personal information provided, will be posted without change at http://www.regulations.gov . Therefore, OSHA cautions individuals about submitting personal information such as Social Security numbers...

OHS Redecorates Exam Rooms to Educate Patients | Poster

Cancer.gov

Occupational Health Services interns are educating patients during their visits via updated exam rooms that now display health-related “themes” like cancer, general health, mental health, and travel safety. They hope the vibrant designs and intriguing facts they’ve displayed will attract attention and benefit patients.

High Throughput Chemical Safety (5th Annual EPA Guided Tour & Research Update talk)

EPA Science Inventory

Understanding the human and ecological risk posed by thousands of existing and emerging commercial chemicals is a critical challenge facing EPA in its mission to protect public health and the environment. Unfortunately many of the chemicals lack exposure information (Egeghy et al...

Provoking "Eureka" moments for effective infection control strategies.

PubMed

Pittet, Didier

2014-01-01

Safety is now a fundamental principle of patient care and a critical component of quality management. Health care-associated infection prevention strategies need to be constantly revisited and updated to be effective. The "Geneva hand hygiene model" is a typical example of a breakthrough innovatory campaign that caught fire and went viral worldwide, thanks to its adoption by the World Health Organization (WHO) as the First Global Patient Safety Challenge. The campaign remains an inspiration for further innovation. To encourage new and disruptive technologies with the potential to improve patient safety through the successful implementation of the WHO multimodal strategy, the University of Geneva Hospitals/WHO Collaborating Centre on Patient Safety, together with the Aesculap Academy, have created a series of "Hand Hygiene Excellence Awards" and "Hand Hygiene Innovation Awards" worldwide.

ACOEM practice guidelines: opioids and safety-sensitive work.

PubMed

Hegmann, Kurt T; Weiss, Michael S; Bowden, Kirk; Branco, Fernando; DuBrueler, Kimberly; Els, Charl; Mandel, Steven; McKinney, David W; Miguel, Rafael; Mueller, Kathryn L; Nadig, Robert J; Schaffer, Michael I; Studt, Larry; Talmage, James B; Travis, Russell L; Winters, Thomas; Thiese, Matthew S; Harris, Jeffrey S

2014-07-01

ACOEM has updated the treatment guidelines concerning opioids. This report highlights the safety-sensitive work recommendation that has been developed. Comprehensive literature reviews were accomplished with article abstraction, critiquing, grading, evidence table compilation, and guideline finalization by a multidisciplinary expert panel to develop evidence-based guidance. A total of 12 moderate-quality studies were identified to address motor vehicle crash risk, and none regarding other work among opioid-using patients. Acute or chronic opioid use is not recommended for patients who perform safety-sensitive jobs. These jobs include operating motor vehicles, other modes of transportation, forklift driving, overhead crane operation, heavy equipment operation and tasks involving high levels of cognitive function and judgment. Quality evidence consistently demonstrates increased risk of vehicle crashes and is recommended as the surrogate for other safety-sensitive work tasks.

An updated numerical simulation of the ground-water flow system for the Castle Lake debris dam, Mount St. Helens, Washington, and implications for dam stability against heave

USGS Publications Warehouse

Roeloffs, Evelyn A.

1994-01-01

A numerical simulation of the ground-water flow system in the Castle Lake debris dam, calibrated to data from the 1991 and 1992 water years, was used to estimate factors of safety against heave and internal erosion. The Castle Lake debris dam, 5 miles northwest of the summit of Mount St. Helens, impounds 19,000 acre-ft of water that could pose a flood hazard in the event of a lake breakout. A new topographic map of the Castle Lake area prior to the 1980 eruption of Mount St. Helens was prepared and used to calculate the thickness of the debris avalanche deposits that compose the dam. Water levels in 22 piezometers and discharges from seeps on the dam face measured several times per year beginning in 1990 supplemented measurements in 11 piezometers and less frequent seep discharge measurements made since 1983. Observations in one group of piezometers reveal heads above the land surface and head gradients favoring upward flow that correspond to factors of safety only slightly greater than 2. The steady-state ground-water flow system in the debris dam was simulated using a threedimensional finite difference computer program. A uniform, isotropic model having the same shape as the dam and a hydraulic conductivity of 1.55 ft/day simulates the correct water level at half the observation points, but is in error by 10 ft or more at other points. Spatial variations of hydraulic conductivity were required to calibrate the model. The model analysis suggests that ground water flows in both directions between the debris dam and Castle Lake. Factors of safety against heave and internal erosion were calculated where the model simulated upward flow of ground water. A critical gradient analysis yields factors of safety as low as 2 near the piezometers where water level observations indicate low factors of safety. Low safety factors are also computed near Castle Creek where slumping was caused by a storm in January, 1990. If hydraulic property contrasts are present in areas of the debris dam unsampled by piezometers, then low safety factors may exist that are not evident in the numerical model analysis. Numerical model simulations showed that lowering Castle Lake by 40 feet increases many factors of safety by 0.1, but increases greater than 1 are limited to the area of 1990 slumping.

The Movement Disorder Society Evidence-Based Medicine Review Update: Treatments for the motor symptoms of Parkinson's disease.

PubMed

Fox, Susan H; Katzenschlager, Regina; Lim, Shen-Yang; Ravina, Bernard; Seppi, Klaus; Coelho, Miguel; Poewe, Werner; Rascol, Olivier; Goetz, Christopher G; Sampaio, Cristina

2011-10-01

The objective was to update previous evidence-based medicine reviews of treatments for motor symptoms of Parkinson's disease published between 2002 and 2005. Level I (randomized, controlled trial) reports of pharmacological, surgical, and nonpharmacological interventions for the motor symptoms of Parkinson's disease between January 2004 (2001 for nonpharmacological) and December 2010 were reviewed. Criteria for inclusion, clinical indications, ranking, efficacy conclusions, safety, and implications for clinical practice followed the original program outline and adhered to evidence-based medicine methodology. Sixty-eight new studies qualified for review. Piribedil, pramipexole, pramipexole extended release, ropinirole, rotigotine, cabergoline, and pergolide were all efficacious as symptomatic monotherapy; ropinirole prolonged release was likely efficacious. All were efficacious as a symptomatic adjunct except pramipexole extended release, for which there is insufficient evidence. For prevention/delay of motor fluctuations, pramipexole and cabergoline were efficacious, and for prevention/delay of dyskinesia, pramipexole, ropinirole, ropinirole prolonged release, and cabergoline were all efficacious, whereas pergolide was likely efficacious. Duodenal infusion of levodopa was likely efficacious in the treatment of motor complications, but the practice implication is investigational. Entacapone was nonefficacious as a symptomatic adjunct to levodopa in nonfluctuating patients and nonefficacious in the prevention/delay of motor complications. Rasagiline conclusions were revised to efficacious as a symptomatic adjunct, and as treatment for motor fluctuations. Clozapine was efficacious in dyskinesia, but because of safety issues, the practice implication is possibly useful. Bilateral subthalamic nucleus deep brain stimulation, bilateral globus pallidus stimulation, and unilateral pallidotomy were updated to efficacious for motor complications. Physical therapy was revised to likely efficacious as symptomatic adjunct therapy. This evidence-based medicine review updates the field and highlights gaps for research. Copyright © 2011 Movement Disorder Society.

Efficacy and safety of direct oral anticoagulants approved for cardiovascular indications: Systematic review and meta-analysis.

PubMed

Makam, Raghavendra Charan P; Hoaglin, David C; McManus, David D; Wang, Victoria; Gore, Joel M; Spencer, Frederick A; Pradhan, Richeek; Tran, Hoang; Yu, Hong; Goldberg, Robert J

2018-01-01

Direct oral anticoagulants (DOACs) have emerged as promising alternatives to vitamin K antagonists (VKAs) for patients with non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE). Few meta-analyses have included all DOACs that have received FDA approval for these cardiovascular indications, and their overall comparisons against VKAs have shortcomings in data and methods. We provide an updated overall assessment of the efficacy and safety of those DOACs at dosages currently approved for NVAF or VTE, in comparison with VKAs. We used data from Phase 3 randomized trials that compared an FDA-approved DOAC with VKA for primary prevention of stroke in patients with NVAF or for treatment of acute VTE. Among trial participants with NVAF, DOAC recipients had a lower risk of stroke or systemic embolism [Pooled Odds Ratio (OR) 0.76, 95% Confidence Interval (CI) (0.68-0.84)], any stroke (0.80, 0.73-0.88), systemic embolism (0.56, 0.34-0.93), and total mortality (0.89, 0.84-0.95). Safety outcomes also showed a lower risk of fatal, major, and intracranial bleeding but higher risk for gastrointestinal bleeding (GIB). Patients with acute VTE randomized to DOACs had comparable risk of recurrent VTE and death (OR 0.88, 95% CI 0.75-1.03), recurrent DVT (0.83, 0.66-1.05), recurrent non-fatal PE (0.97, 0.75-1.25), and total mortality (0.94, 0.79-1.12). Safety outcomes for DOACs showed a lower risk of major, fatal, and intracranial bleeding, but similar risk of GIB. Patients receiving DOACs for NVAF had predominantly superior efficacy and safety. Patients who were treated with DOACs for acute VTE had non-inferior efficacy, but an overall superior safety profile.

Multi-Hazard Assessment of Scour Damaged Bridges with UAS-Based Measurements

NASA Astrophysics Data System (ADS)

Özcan, O.; Ozcan, O.

2017-12-01

Flood and stream induced scour occurring in bridge piers constructed on rivers is one of the mostly observed failure reasons in bridges. Scour induced failure risk in bridges and determination of the alterations in bridge safety under seismic effects has the ultimate importance. Thus, for the determination of bridge safety under the scour effects, the scour amount under bridge piers should be designated realistically and should be tracked and updated continuously. Hereby, the scour induced failures in bridge foundation systems will be prevented and bridge substructure design will be conducted safely. In this study, in order to measure the amount of scour in bridge load bearing system (pile foundations and pile abutments) and to attain very high definition 3 dimensional models of river flood plain for the flood analysis, unmanned aircraft system (UAS) based measurement methods were implemented. UAS based measurement systems provide new and practical approach and bring high precision and reliable solutions considering recent measurement systems. For this purpose, the reinforced concrete (RC) bridge that is located on Antalya Boğaçayı River, Turkey and that failed in 2003 due to flood-induced scour was selected as the case study. The amount of scour occurred in bridge piers and piles was determined realistically and the behavior of bridge piers under scour effects was investigated. Future flood effects and the resultant amount of scour was determined with HEC-RAS software by using digital surface models that were obtained at regular intervals using UAS for the riverbed. In the light of the attained scour measurements and expected scour after a probable flood event, the behavior of scour damaged RC bridge was investigated by pushover and time history analyses under lateral and vertical seismic loadings. In the analyses, the load and displacement capacity of bridge was observed to diminish significantly under expected scour. Thus, the deterioration in multi hazard performance of the bridge was monitored significantly in the light of updated bridge load bearing system capacity. Regarding the case study, UAS based and continuously updated bridge multi hazard risk detection system was established that can be used for bridges located on riverbed.

RECERTIFICATION OF THE MODEL 9977 RADIOACTIVE MATERIAL PACKAGING

DOE Office of Scientific and Technical Information (OSTI.GOV)

Abramczyk, G.; Bellamy, S.; Loftin, B.

2013-06-05

The Model 9977 Packaging was initially issued a Certificate of Compliance (CoC) by the Department of Energy’s Office of Environmental Management (DOE-EM) for the transportation of radioactive material (RAM) in the Fall of 2007. This first CoC was for a single radioactive material and two packing configurations. In the five years since that time, seven Addendums have been written to the Safety Analysis Report for Packaging (SARP) and five Letter Amendments have been written that have authorized either new RAM contents or packing configurations, or both. This paper will discuss the process of updating the 9977 SARP to include allmore » the contents and configurations, including the addition of a new content, and its submittal for recertification.« less

Using secure messaging to update medications list in ambulatory care setting.

PubMed

Raghu, T S; Frey, Keith; Chang, Yu-Hui; Cheng, Meng-Ru; Freimund, Sharon; Patel, Asha

2015-10-01

This study analyzed patient adoption of secure messaging to update medication list in an ambulatory care setting. The objective was to establish demographic differences between users and non-users of secure messaging for medications list update. Efficiency of secure messaging for the updates was compared to fax and telephone based updates. The study used a retrospective, cross-sectional study of patient medical records and pharmacy call logs at Mayo Clinic, Arizona from December 2012 to May 2013, approximately one year after organizing a pharmacy call center for medication updates. A subgroup analysis during a 2-week period was used to measure time to complete update. Main dependent variable is the frequency of medication list updates over the study duration. Technician time required for the update was also utilized. A total of 22,495 outpatient visits were drawn and 18,702 unique patients were included in the primary analysis. A total of 402 unique patients were included in sub-group analysis. Secure message response rate (49.5%) was statistically significantly lower than that for phone calls (54.8%, p<0.001). Time to complete the update was significantly higher for faxed medication lists (Wilcoxon rank-sum tests, p<0.001) when compared to those for secure message or phone. Around 50% of the patients respond to medication update requests before office visit when contacted using phone calls and secure messages. Given the demographic differences between users and non-users of patient portal, mixed mode communication with patients is likely to be the norm for the foreseeable future in outpatient settings. Copyright © 2015. Published by Elsevier Ireland Ltd.

Update on biosimilars in inflammatory bowel disease: Position and recommendations in Mexico.

PubMed

Mayoral-Zavala, A; Esquivel-Aguilar, A; Del Real-Calzada, C M; Gutiérrez-Grobe, Y; Ramos-García, J; Rocha-Ramírez, J L; Rojas-Illanes, M F; Rubio-Martínez, B; Sánchez-Chávez, X; Yamamoto-Furusho, J K

2018-04-20

The biotechnology-derived medicines known as biosimilars are defined as non-originator treatments that have demonstrated quality, efficacy, and safety comparable to the reference biologic drug. Clinical trials have shown that the infliximab biosimilar, CT-P13, and the candidates for the adalimumab biosimilars, ABP 501 and ZRC 3197, are not significantly different, with respect to efficacy and safety, from the originator drugs in patients with other autoimmune diseases. However, controversy has arisen over the use of biosimilars in inflammatory bowel disease, due to the incipient evidence not only in patients with no previous biotechnology treatment, but also in patients in remission, that could be switched to a biosimilar for non-medical reasons. The present review is the first critical analysis by different specialists in the area of gastroenterology on the use of biosimilars in inflammatory bowel disease, the evidence on interchangeability, the extrapolation of indications, efficacy, safety, immunogenicity, and the clinical impact of the Mexican health regulations. The aim of our review was to make the positioning and recommendations of these new therapeutic options known, given that they have a potential cost-benefit for both patients and healthcare institutions. Copyright © 2018 Asociación Mexicana de Gastroenterología. Publicado por Masson Doyma México S.A. All rights reserved.

Utilizing Flight Data to Update Aeroelastic Stability Estimates

NASA Technical Reports Server (NTRS)

Lind, Rick; Brenner, Marty

1997-01-01

Stability analysis of high performance aircraft must account for errors in the system model. A method for computing flutter margins that incorporates flight data has been developed using robust stability theory. This paper considers applying this method to update flutter margins during a post-flight or on-line analysis. Areas of modeling uncertainty that arise when using flight data with this method are investigated. The amount of conservatism in the resulting flutter margins depends on the flight data sets used to update the model. Post-flight updates of flutter margins for an F/A-18 are presented along with a simulation of on-line updates during a flight test.

Ground Vibration Test of the Aerostructure Test Wing 2

NASA Technical Reports Server (NTRS)

Herrera, Claudia; Moholt, Matthew

2009-01-01

The Aerostructures Test Wing (ATW) was developed to test unique concepts for flutter prediction and control synthesis. A follow-on to the successful ATW, denoted ATW2, was fabricated as a test bed to validate a variety of instrumentation in flight and to collect data for development of advanced signal processing algorithms for flutter prediction and aviation safety. As a means to estimate flutter speed, a ground vibration test (GVT) was performed. The results of a GVT are typically utilized to update structural dynamics finite element (FE) models used for flutter analysis. In this study, two GVT methodologies were explored to determine which nodes provide the best sensor locations: (i) effective independence and (ii) kinetic energy sorting algorithms. For measurement, ten and twenty sensors were used for three and 10 target test modes. A total of six accelerometer configurations measured frequencies and mode shapes. This included locations used in the original ATW GVT. Moreover, an optical measurement system was used to acquire data without mass effects added by conventional sensors. A considerable frequency shift was observed in comparing the data from the accelerometers to the optical data. The optical data provided robust data for use of the ATW2 finite element model update.

Local health rules and building regulations: a survey on local hygiene and building regulations in Italian municipalities.

PubMed

Gola, Marco; Signorelli, Carlo; Buffoli, Maddalena; Rebecchi, Andrea; Capolongo, Stefano

2017-01-01

WHO has highlighted the need to strengthen the relationship between health and built environment factors, such as inappropriate housing conditions. Local Health Rules (LHRs) and Building Regulations (BRs) are tools which provide safety and building hygiene in construction practices. Currently the Italian Government is considering to establish a National Building Regulation and, related to the following purpose, this paper presents a survey on the status of adoption and updating of LHRs and BRs in Italian municipalities. The current Italian state of LHRs, BRs and Municipal Development Plans (MDPs) have been examined by a survey considering a sample of about 550 cities, with different demo graphic and geographic features, starting from the previous research work by Signorelli et al. (1999). The analysis underlines a serious shortage of updated LHRs, especially in small and medium-sized municipalities whereas BRs and MDPs are widespread. Only 30% of them are previously approved and validated by Local Health Authorities. Starting from a survey, the present scenario of Building Regulations requires the introduction of further performance guidelines instead of normative ones and, therefore, the current actions to give rise to a National Building Regulation could be integrated by building hygiene contents of LHRs.

cDNA Microarray Screening in Food Safety

PubMed Central

ROY, SASHWATI; SEN, CHANDAN K

2009-01-01

The cDNA microarray technology and related bioinformatics tools presents a wide range of novel application opportunities. The technology may be productively applied to address food safety. In this mini-review article, we present an update highlighting the late breaking discoveries that demonstrate the vitality of cDNA microarray technology as a tool to analyze food safety with reference to microbial pathogens and genetically modified foods. In order to bring the microarray technology to mainstream food safety, it is important to develop robust user-friendly tools that may be applied in a field setting. In addition, there needs to be a standardized process for regulatory agencies to interpret and act upon microarray-based data. The cDNA microarray approach is an emergent technology in diagnostics. Its values lie in being able to provide complimentary molecular insight when employed in addition to traditional tests for food safety, as part of a more comprehensive battery of tests. PMID:16466843

Neuro-oncology update: radiation safety and nursing care during interstitial brachytherapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Randall, T.M.; Drake, D.K.; Sewchand, W.

Radiation control and safety are major considerations for nursing personnel during the care of patients receiving brachytherapy. Since the theory and practice of radiation applications are not part of the routine curriculum of nursing programs, the education of nurses and other health care professionals in radiation safety procedures is important. Regulatory agencies recommend that an annual safety course be given to all persons frequenting, using, or associated with patients containing radioactive materials. This article presents pertinent aspects of the principles and procedures of radiation safety, the role of personnel dose-monitoring devices, and the value of additional radiation control features, suchmore » as a lead cubicle, during interstitial brain implants. One institution's protocol and procedures for the care of high-intensity iridium-192 brain implants are discussed. Preoperative teaching guidelines and nursing interventions included in the protocol focus on radiation control principles.« less

The administration of probiotics and synbiotics in immune compromised adults: is it safe?

PubMed

Van den Nieuwboer, M; Brummer, R J; Guarner, F; Morelli, L; Cabana, M; Claasen, E

2015-03-01

This study aimed to systematically evaluate safety of probiotics and synbiotics in immune compromised adults (≥18 years). Safety was analysed using the Common Terminology Clinical Adverse Events (CTCAE version 4.0) classification, thereby providing an update on previous reports using the most recent available clinical data (2008-2013). Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. Analysis of 57 clinical studies indicates that probiotic and/or synbiotic administration in immune compromised adults is safe with regard to the current evaluated probiotic strains, dosages and duration. Individuals were considered immune compromised if HIV-infected, critically ill, underwent surgery or had an organ- or an autoimmune disease. There were no major safety concerns in the study, as none of the serious adverse events (AE)s were related, or suspected to be related, to the probiotic or synbiotic product and the study products were well tolerated. Overall, AEs occurred less frequent in immune compromised subjects receiving probiotics and/or synbiotics compared to the control group. In addition, the results demonstrated a flaw in precise reporting and classification of AE in most studies. Furthermore, generalisability of conclusions are greatly limited by the inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes. We argue that standardised reporting on adverse events (CTCAE) in 'food' studies should be obligatory, thereby improving reliability of data and re-enforcing the safety profile of probiotics.

Child passenger safety practices in the U.S.: disparities in light of updated recommendations.

PubMed

Macy, Michelle L; Freed, Gary L

2012-09-01

Children are best protected in motor vehicle collisions when properly using the appropriate restraint and sitting in a rear row. Racial and ethnic disparities have been reported in injury statistics and use of any restraint; however, predictors of safety seat use, being unrestrained, and sitting in the front seat have not been explored previously. To determine factors associated with child passenger safety practices by race/ethnicity in a national sample of child passengers aged <13 years. Secondary analysis conducted in 2011 of the 2007, 2008, and 2009 National Survey of the Use of Booster Seats in which child passenger restraint use was observed directly. Age-stratified, survey-weighted chi-square and logistic regression analyses were conducted. Restraint use was observed for 21,476 children aged <13 years. A decline in child safety seat use and increase in being unrestrained were observed with increasing child age. In multivariate analyses, race/ethnicity, unrestrained drivers, and sitting in the front seat were associated with lower odds of child safety seat use among children aged <8 years. Older child age was associated with sitting in the front seat and being unrestrained. The presence of multiple child passengers was associated with lower odds of sitting in the front but higher odds of being unrestrained. Few children use the recommended child passenger restraints. Understanding the reasons for the suboptimal child passenger restraint practices identified in this study is essential for the development of effective programs to reduce or eliminate preventable motor vehicle collision-related injuries. Copyright © 2012 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research☆

PubMed Central

Rossi, Simone; Hallett, Mark; Rossini, Paolo M.; Pascual-Leone, Alvaro

2011-01-01

This article is based on a consensus conference, which took place in Certosa di Pontignano, Siena (Italy) on March 7–9, 2008, intended to update the previous safety guidelines for the application of transcranial magnetic stimulation (TMS) in research and clinical settings. Over the past decade the scientific and medical community has had the opportunity to evaluate the safety record of research studies and clinical applications of TMS and repetitive TMS (rTMS). In these years the number of applications of conventional TMS has grown impressively, new paradigms of stimulation have been developed (e.g., patterned repetitive TMS) and technical advances have led to new device designs and to the real-time integration of TMS with electroencephalography (EEG), positron emission tomography (PET) and functional magnetic resonance imaging (fMRI). Thousands of healthy subjects and patients with various neurological and psychiatric diseases have undergone TMS allowing a better assessment of relative risks. The occurrence of seizures (i.e., the most serious TMS-related acute adverse effect) has been extremely rare, with most of the few new cases receiving rTMS exceeding previous guidelines, often in patients under treatment with drugs which potentially lower the seizure threshold. The present updated guidelines review issues of risk and safety of conventional TMS protocols, address the undesired effects and risks of emerging TMS interventions, the applications of TMS in patients with implanted electrodes in the central nervous system, and safety aspects of TMS in neuroimaging environments. We cover recommended limits of stimulation parameters and other important precautions, monitoring of subjects, expertise of the rTMS team, and ethical issues. While all the recommendations here are expert based, they utilize published data to the extent possible. PMID:19833552

Development of an Updated Societal-Risk Goal for Nuclear Power Safety

DOE Office of Scientific and Technical Information (OSTI.GOV)

Vicki Bier; Michael Corradini; Robert Youngblood

2014-07-01

This report briefly summarizes work done in FY 2013 on the subject LDRD. The working hypothesis is that societal disruption should be addressed in a safety goal. This is motivated by the point that the Fukushima disaster resulted in very little public dose, but enormous societal disruption; a goal that addressed societal disruption would fill a perceived gap in the US NRC safety goal structure. This year's work entailed analyzing the consequences of postulated accidents at various reactor sites in the US, specifically with a view to quantifying the number of people relocated and the duration of their relocation, tomore » see whether this makes sense as a measure of societal disruption.« less

A Web-based Alternative Non-animal Method Database for Safety Cosmetic Evaluations

PubMed Central

Kim, Seung Won; Kim, Bae-Hwan

2016-01-01

Animal testing was used traditionally in the cosmetics industry to confirm product safety, but has begun to be banned; alternative methods to replace animal experiments are either in development, or are being validated, worldwide. Research data related to test substances are critical for developing novel alternative tests. Moreover, safety information on cosmetic materials has neither been collected in a database nor shared among researchers. Therefore, it is imperative to build and share a database of safety information on toxicological mechanisms and pathways collected through in vivo, in vitro, and in silico methods. We developed the CAMSEC database (named after the research team; the Consortium of Alternative Methods for Safety Evaluation of Cosmetics) to fulfill this purpose. On the same website, our aim is to provide updates on current alternative research methods in Korea. The database will not be used directly to conduct safety evaluations, but researchers or regulatory individuals can use it to facilitate their work in formulating safety evaluations for cosmetic materials. We hope this database will help establish new alternative research methods to conduct efficient safety evaluations of cosmetic materials. PMID:27437094

A Web-based Alternative Non-animal Method Database for Safety Cosmetic Evaluations.

PubMed

Kim, Seung Won; Kim, Bae-Hwan

2016-07-01

Animal testing was used traditionally in the cosmetics industry to confirm product safety, but has begun to be banned; alternative methods to replace animal experiments are either in development, or are being validated, worldwide. Research data related to test substances are critical for developing novel alternative tests. Moreover, safety information on cosmetic materials has neither been collected in a database nor shared among researchers. Therefore, it is imperative to build and share a database of safety information on toxicological mechanisms and pathways collected through in vivo, in vitro, and in silico methods. We developed the CAMSEC database (named after the research team; the Consortium of Alternative Methods for Safety Evaluation of Cosmetics) to fulfill this purpose. On the same website, our aim is to provide updates on current alternative research methods in Korea. The database will not be used directly to conduct safety evaluations, but researchers or regulatory individuals can use it to facilitate their work in formulating safety evaluations for cosmetic materials. We hope this database will help establish new alternative research methods to conduct efficient safety evaluations of cosmetic materials.